Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02106195
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2014-04-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718240', 'term': 'belumosudil'}, {'id': 'C000619755', 'term': 'KD025'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karin.herrera@kadmon.com', 'phone': '833-900-5366', 'title': 'Associate VP, Clinical Operations', 'organization': 'Kadmon Corporation, LLC'}, 'certainAgreement': {'otherDetails': "The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results. The sponsor cannot require changes to the study results in the communication except to remove sponsor's confidential information. Sponsor cannot unilaterally extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and 4 weeks of follow-up.', 'description': 'The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 was used. The Clinical Symptom and Adverse Event Grading scale was used for grading toxicities.', 'eventGroups': [{'id': 'EG000', 'title': 'Belumosudil 200 mg PO QD', 'description': 'Subjects who received belumosudil 200 mg orally daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Transaminase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Anastomotic ulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Tooth ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'seriousEvents': [{'term': 'Nausea', 'notes': 'Same subject had SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Vomiting', 'notes': 'Same subject had SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Anastomotic ulcer', 'notes': 'Same subject had SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Nephrolithiasis', 'notes': 'Same subject had SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belumosudil 200 mg PO QD', 'description': 'Subjects who received at least 1 dose of belumosudil 200 mg orally daily'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade ≥3 AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade ≥3 Related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks:Up to 4 weeks screening (depending on signed informed consent + 4 weeks treatment + 4 weeks follow-up', 'description': 'To evaluate the safety and tolerability of 200 mg of belumosudil administered PO QD to subjects for treatment of psoriasis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All subjects who received at least 1 dose of belumosudil 200 mg'}, {'type': 'SECONDARY', 'title': 'Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belumosudil 200 mg PO QD', 'description': 'Subjects receiving 200 mg of belumosudil daily'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '8.41', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (Day 28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '9.49', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (Day 56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '3.41', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.54', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.324', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.04', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change from Baseline to Day 28'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\n\nThe measures are the changes in PASI score at Week 4 from baseline and Week 8 from baseline. Negative changes are favorable; positive changes are unfavorable.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 8 subjects who received belumosudil 200 mg PO QD. 7 subjects available at follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belumosudil 200 mg PO QD', 'description': 'Subjects receiving belumosudil 200 mg orally once daily for up to 28 days'}], 'classes': [{'title': '4 weeks: 75% to 100%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 50% to 74% clearing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 25% to 49% clearing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: 0 to 24% clearing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks: Worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: 75% to 100%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: 50% to 74% clearing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: 25% to 49% clearing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: 0% to 24% clearing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '8 weeks: Missing (no data)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up', 'description': 'PGA score after treatment with belumosudil 200 mg PO QD at 4 weeks (28 days treatment) and at 8 weeks (additional 4 weeks follow-up).\n\nCategories: 100% = clear; 75% to 99% clearing (Excellent) = marked improvement, nearly normal skin texture, some erythema may be present; 50% to 74% clear (Good) = moderate improvement, plaque has cleared to point of small scattered papules with normal intervening epidermis; 25% to 49% clearing (Fair) = slight improvement, decrease in scaling and softening of plaque; 0% to 24% clearing (Poor) = little or no change in scaling, erythema, or plaque elevation; Worse', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 8 subjects had PGA scoring at Day 29 and at the follow-up visit (30 days after last dose of study drug)'}, {'type': 'SECONDARY', 'title': 'PK: Cmax and Cmin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Drug KD025', 'description': 'Study drug belumosudil'}, {'id': 'OG001', 'title': 'Metabolite M1', 'description': 'Metabolite KD025 M1 of parent drug KD025.'}, {'id': 'OG002', 'title': 'Metabolite M2', 'description': 'Metabolite KD025 M2 of parent drug KD025.'}], 'classes': [{'title': 'Cmax: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1240', 'spread': '704', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '221', 'spread': '165', 'groupId': 'OG002'}]}]}, {'title': 'Cmax: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '810', 'spread': '475', 'groupId': 'OG000'}, {'value': '15.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available since only 1 participant was analyzed for the assessment.', 'groupId': 'OG001'}, {'value': '131', 'spread': '152', 'groupId': 'OG002'}]}]}, {'title': 'Cmin: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.6', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '9.16', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '6.13', 'groupId': 'OG002'}]}]}, {'title': 'Cmin: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '10.7', 'spread': 'NA', 'comment': 'Standard Deviation is not available since only 1 participant was analyzed for the assessment.', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '7.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measures:\n\nCmax = maximum observed plasma concentration; Cmin = minimum observed plasma concentration over 1 dosing period; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2.\n\nDay 1 Cmax: 8 subjects each in KD025 and M2, and 6 subjects in M1. Day 28 Cmax: 4 subjects each in KD025 and M2, and 1 subject in M1.\n\nDay 1 Cmin: 8 subjects each in KD025 and M2, and 3 subjects in M1. Day 28 Cmin: 4 subjects each in KD025 and M2, and 1 subject in M1.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject excluded from all the descriptive statistics due to a mix-up of samples between predose and 4 hours (KD025, M1 and M2); Two subjects had no measurable concentrations observed in their profiles for M1 at Day 1'}, {'type': 'SECONDARY', 'title': 'PK: AUC(0-24) and AUC(Inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Drug KD025', 'description': 'Study drug belumosudil'}, {'id': 'OG001', 'title': 'Metabolite M2', 'description': 'Metabolite KD025 M2 of parent drug KD025.'}], 'classes': [{'title': 'AUC(0-24): Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7360', 'spread': '3180', 'groupId': 'OG000'}, {'value': '1040', 'spread': '545', 'groupId': 'OG001'}]}]}, {'title': 'AUC(0-24): Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5500', 'spread': '3790', 'groupId': 'OG000'}, {'value': '162', 'spread': '2320', 'groupId': 'OG001'}]}]}, {'title': 'AUC(inf) from Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8230', 'spread': '3600', 'groupId': 'OG000'}, {'value': '1120', 'spread': '680', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measures:\n\nAUC(0-24) = area under concentration time-curve from pre-dose (time 0) to 24 hours post-dose; AUC(inf) = area under concentration time-curve extrapolated from Day 1 to infinity; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AUC(0-24) Day 1: 7 subjects in KD025 and 3 subjects in M2. AUC(0-24) Day 28: 4 subjects in KD025 and 2 subjects in M2. AUC(inf): 6 subjects in KD025 and 3 subject in M2. Neither AUC(0-24) nor AUC(inf) were calculated for M1.'}, {'type': 'SECONDARY', 'title': 'PK: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Drug KD025', 'description': 'Study drug belumosudil'}, {'id': 'OG001', 'title': 'Metabolite M1', 'description': 'Metabolite KD025 M1 of parent drug KD025.'}, {'id': 'OG002', 'title': 'Metabolite M2', 'description': 'Metabolite KD025 M2 of parent drug KD025.'}], 'classes': [{'title': 'Tmax: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '7.92'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '7.92'}]}]}, {'title': 'Tmax: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.13'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measure:\n\nTmax = time of maximum observed plasma concentration. Day 1 Tmax: 7 subjects each in KD025 and M2, and 5 subjects in M1. Day 28 Tmax: 4 subjects each in KD025 and M2, and 1 subject in M1.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 1: 7 subjects each in KD025 and M2, and 5 subjects in M1. Day 28: 4 subjects each in KD025 and M2, and 1 subject in M1.'}, {'type': 'SECONDARY', 'title': 'PK: t(1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parent Drug KD025', 'description': 'Study drug belumosudil'}, {'id': 'OG001', 'title': 'Metabolite M2', 'description': 'Metabolite KD025 M2 of parent drug KD025.'}], 'classes': [{'title': 't(1/2): Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.08', 'spread': '0.681', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 't(1/2): Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.27', 'spread': '0.692', 'groupId': 'OG000'}, {'value': '2.26', 'spread': 'NA', 'comment': 'Standard Deviation not available since only 1 participant was analyzed for the assessment.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'KD025 = Parent Drug KD025; KD025 M2 = Metabolite M2; t(1/2) = apparent terminal elimination half-life', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from all descriptive statistics due to a mix-up of samples between pre-dose and 4 hours on Day 1.\n\nThree subjects were excluded from day 28 statistics due to varying protocol deviations. Four additional subjects were excluded from M1 Day 28. No data were collected for Metabolite M1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belumosudil 200 mg PO QD', 'description': '8 subjects with moderately severe psoriasis who had failed at least 1 line of systemic therapy administered belumosudil 200 mg orally QD for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Includes all 3 periods of study: Screening, Treatment, Post-treatment', 'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Open-label, Phase 2a, single-arm study of subjects with moderately severe plaque psoriasis who had been stable for 6 months and had failed at least 1 line of systemic therapy. Subjects were recruited at 1 site in the U.S.', 'preAssignmentDetails': 'Screening assessments occurred within 28 days prior to assignment and included informed consent, medical/demographic history, physical exam, vital signs, clinical laboratory tests, ECG, urine pregnancy, skin punch biopsy, PK, Psoriasis Area and Severity Index (PASI) scoring, Physician Global Assessment (PGA) scoring, and concomitant AE assessments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Belumosudil 200 mg PO QD', 'description': 'Belumosudil 200 mg (two 100 mg capsules) orally once daily for 28 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47.6', 'spread': '10.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.42', 'spread': '6.539', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (kg/m\\^2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.61', 'groupId': 'BG000', 'lowerLimit': '21.2', 'upperLimit': '41.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Body mass index (kg/m\\^2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2014-10-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2014-04-02', 'dispFirstSubmitQcDate': '2014-10-09', 'resultsFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2014-04-03', 'dispFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-13', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Up to 12 weeks:Up to 4 weeks screening (depending on signed informed consent + 4 weeks treatment + 4 weeks follow-up', 'description': 'To evaluate the safety and tolerability of 200 mg of belumosudil administered PO QD to subjects for treatment of psoriasis'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8', 'timeFrame': '8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\n\nThe measures are the changes in PASI score at Week 4 from baseline and Week 8 from baseline. Negative changes are favorable; positive changes are unfavorable.'}, {'measure': 'Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8', 'timeFrame': '8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up', 'description': 'PGA score after treatment with belumosudil 200 mg PO QD at 4 weeks (28 days treatment) and at 8 weeks (additional 4 weeks follow-up).\n\nCategories: 100% = clear; 75% to 99% clearing (Excellent) = marked improvement, nearly normal skin texture, some erythema may be present; 50% to 74% clear (Good) = moderate improvement, plaque has cleared to point of small scattered papules with normal intervening epidermis; 25% to 49% clearing (Fair) = slight improvement, decrease in scaling and softening of plaque; 0% to 24% clearing (Poor) = little or no change in scaling, erythema, or plaque elevation; Worse'}, {'measure': 'PK: Cmax and Cmin', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measures:\n\nCmax = maximum observed plasma concentration; Cmin = minimum observed plasma concentration over 1 dosing period; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2.\n\nDay 1 Cmax: 8 subjects each in KD025 and M2, and 6 subjects in M1. Day 28 Cmax: 4 subjects each in KD025 and M2, and 1 subject in M1.\n\nDay 1 Cmin: 8 subjects each in KD025 and M2, and 3 subjects in M1. Day 28 Cmin: 4 subjects each in KD025 and M2, and 1 subject in M1.'}, {'measure': 'PK: AUC(0-24) and AUC(Inf)', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measures:\n\nAUC(0-24) = area under concentration time-curve from pre-dose (time 0) to 24 hours post-dose; AUC(inf) = area under concentration time-curve extrapolated from Day 1 to infinity; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2.'}, {'measure': 'PK: Tmax', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Pharmacokinetic measure:\n\nTmax = time of maximum observed plasma concentration. Day 1 Tmax: 7 subjects each in KD025 and M2, and 5 subjects in M1. Day 28 Tmax: 4 subjects each in KD025 and M2, and 1 subject in M1.'}, {'measure': 'PK: t(1/2)', 'timeFrame': 'Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose', 'description': 'KD025 = Parent Drug KD025; KD025 M2 = Metabolite M2; t(1/2) = apparent terminal elimination half-life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the safety and tolerability of 200 mg of belumosudil administered orally once daily for 28 days.', 'detailedDescription': 'This will be a Phase 2a, open-label, single-arm, safety and tolerability study of belumosudil given daily for treatment of psoriasis.\n\nEight subjects with moderately severe psoriasis who have failed at least 1 line of systemic therapy will be enrolled.\n\nTreatment Period Eligible subjects who have failed at least 1 line of systemic therapy will be entered and treated for 4 weeks (28 days) with 200 mg of belumosudil given orally once daily (QD).\n\nSubjects will undergo medical history evaluations, physical examinations, vital sign measurements, weight, adverse event assessments, concomitant medication assessments, and laboratory testing including but not limited to blood sample collection for hematology and chemistry, urinalysis, coagulation, lipid panel, electrocardiogram, pregnancy test for females of childbearing potential, testing with the Psoriasis Area and Severity Index (PASI) scale and Physician Global Assessment (PGA) scale, and pharmacokinetic sampling.\n\nFollow-up Period:\n\nVisit will occur 4 weeks after the last dose of study drug in the Treatment Period of the study. This visit must be done within ± 3 days of the scheduled visit. The same assessments will be performed as in the Treatment Period.\n\nThe duration of the study is 12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and 4 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and has failed at least one line of systemic therapy and is a candidate for additional systemic therapy.\n* Had a PASI of ≥12\n* At least 10% of body surface area that is affected by plaque psoriasis.\n* Willing to avoid tanning devices or sun bathing.\n* Willing to forgo systemic and topical treatments for psoriasis during the course of the study.\n* Adequate bone marrow function\n* Negative urine pregnancy test (for women of childbearing potential)\n* Agree to use a highly effective method of birth control (\\< 1% per year failure rate) during the study and for 1 month after the termination of the study.\n* Willing to complete all study measurements and assessments in compliance with the protocol.\n\nExclusion Criteria:\n\n* Non-plaque or drug-induced psoriasis\n* Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp\n* Using any topical therapy except for the following:\n\n 1. Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry\n 2. Immunosuppressive therapies for 4 weeks prior to study entry\n 3. Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry\n 4. Biologic therapies for 3 months prior to study entry.\n* Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.\n* Viral, fungal, or bacterial skin infection.\n* Pregnant or lactating woman.\n* Currently participating in another study with an investigational drug or within 28 days of study entry\n* History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study\n* History or presence of any of the following:\n\n 1. Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 1.5 × the upper limit of normal (ULN) at screening\n 2. Renal disease and/or serum creatinine \\> 1.5xULN at screening\n* Has QTc(f) intervals of \\> 450 msec at the screening or pre-dose ECG\n* Subject is receiving any drugs known to prolong the QTc interval, including any anti-arrhythmic medications within 2 weeks prior to screening\n* Subject is receiving any drug that is a strong CYP enzyme inhibitor\n* Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme\n* Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor.'}, 'identificationModule': {'nctId': 'NCT02106195', 'briefTitle': 'A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kadmon Corporation, LLC'}, 'officialTitle': 'A Phase 2a, Open-label Study to Evaluate the Safety and Tolerability of KD025 [Belumosudil] Treatment in Subjects With Moderately Severe Psoriasis Vulgaris Who Have Failed First-line Therapy', 'orgStudyIdInfo': {'id': 'KD025-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Belumosudil 200 mg', 'description': 'Belumosudil 200 mg (two 100 mg capsules) orally once daily for 28 days', 'interventionNames': ['Drug: Belumosudil']}], 'interventions': [{'name': 'Belumosudil', 'type': 'DRUG', 'otherNames': ['Rezurock (brand name)', 'KD025', 'SLx-2119'], 'armGroupLabels': ['Belumosudil 200 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health, Dept of Dermatology', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kadmon Corporation, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}