Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-04 @ 8:12 PM
Study NCT ID:
NCT06476834
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality, SAEs and Other AEs from the dose of study medication through 30 days (assessed for up to 30 days).', 'description': 'All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '211.0', 'spread': '59.5', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '74.09', 'spread': '55.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '1656', 'spread': '54.5', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '1289', 'spread': '58.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 up to 24 hours post dose', 'description': 'AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '1876', 'spread': '57.9', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '1767', 'spread': '61.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '78.18', 'spread': '57.9', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '73.61', 'spread': '61.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '0.05021', 'spread': '102.8', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '0.03393', 'spread': '107.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From first dose day 1 up to 24 hours post dose', 'description': 'AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '0.05395', 'spread': '106.0', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '0.04230', 'spread': '116.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '3.241', 'spread': '50.9', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '15.76', 'spread': '57.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Average Estimated Daily Infant Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01586', 'spread': '58.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data.', 'unitOfMeasure': 'mg/kg/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'PRIMARY', 'title': 'Average Relative Infant Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '12.11', 'spread': '53.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': "Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data.", 'unitOfMeasure': 'Percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '62.56', 'spread': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '4.797', 'spread': '36.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '587.2', 'spread': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '128.3', 'spread': '36.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '511.0', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '81.79', 'spread': '39.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 up to 24 hours post dose', 'description': 'AUC(0-24) defined as the area under the plasma concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '575.1', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '104.5', 'spread': '52.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.00'}]}]}, {'title': 'BMT-153261', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Pharmacokinetic (PK) participants who have at least 1 evaluable PK parameter.'}, {'type': 'SECONDARY', 'title': 'Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'title': 'BMS-986165', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.47', 'spread': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'BMT-153261', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.346', 'spread': '36.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 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'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Blood samples were collected to assess the abnormalities in laboratory parameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started=Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'comment': 'Completed=Completing the Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All participants received study treatment at one site in the United States of America.', 'preAssignmentDetails': 'Total 8 participants received study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Deucravacitinib 9 mg', 'description': 'Participants received Deucravacitinib at a dose of 9 mg once daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '6.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-03', 'size': 4612429, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-24T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-06-21', 'resultsFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-19', 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 up to 24 hours post dose', 'description': 'AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'From first dose day 1 up to 24 hours post dose', 'description': 'AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.'}, {'measure': 'Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.'}, {'measure': 'Average Estimated Daily Infant Dose', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data.'}, {'measure': 'Average Relative Infant Dose', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': "Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data."}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 up to 24 hours post dose', 'description': 'AUC(0-24) defined as the area under the plasma concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Tmax is defined as the time taken to reach the maximum observed plasma concentration (Cmax) of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma', 'timeFrame': 'First dose day 1 to day 4 up to 72 hours', 'description': 'Cavg defined as the average plasma concentration of BMS-986165 and BMT-153261 in plasma.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Blood samples were collected to assess the abnormalities in laboratory parameters.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the dose of study medication through 30 days (assessed for up to 30 days)', 'description': 'Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations.\n* Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected.\n* Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.\n* Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).\n\nExclusion Criteria\n\n* Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study.\n* Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention.\n* Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts.\n* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06476834', 'briefTitle': 'A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants', 'orgStudyIdInfo': {'id': 'IM011-1123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deucravacitinib Administration', 'interventionNames': ['Drug: Deucravacitinib']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['BMS-986165', 'SOTYKTU®'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Deucravacitinib Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113-2246', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See Plan Description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}