Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT07167758
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating TRIV-509 in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with improvement of AD at Week 16', 'timeFrame': 'Baseline to Week 16'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with improvement of AD at Week 16', 'timeFrame': 'Baseline through Week 16'}, {'measure': 'Percentage of participants with TEAEs.', 'timeFrame': 'For 16 Weeks'}, {'measure': 'Percentage of participants with SAEs.', 'timeFrame': 'For 16 Weeks'}, {'measure': 'Percentage of participants with anti-TRIV-509 antibodies', 'timeFrame': 'For 16 Weeks'}, {'measure': 'Serum concentration of TRIV-509', 'timeFrame': 'For 16 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.\n\nParticipants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.\n\nThe study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has Atopic Dermatitis.\n* Has moderate to severe, active and symptomatic AD\n\nExclusion Criteria:\n\n* Severe or uncontrolled medical conditions.\n* Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.'}, 'identificationModule': {'nctId': 'NCT07167758', 'briefTitle': 'A Study Evaluating TRIV-509 in Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Triveni Bio'}, 'officialTitle': 'A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '509-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First TRIV-509 then Placebo', 'interventionNames': ['Drug: TRIV-509', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'First Placebo then TRIV-509', 'interventionNames': ['Drug: TRIV-509', 'Drug: Placebo']}], 'interventions': [{'name': 'TRIV-509', 'type': 'DRUG', 'description': 'TRIV-509 (Subcutaneous injection)', 'armGroupLabels': ['First Placebo then TRIV-509', 'First TRIV-509 then Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drug: Placebo (Matching Placebo subcutaneous injection)', 'armGroupLabels': ['First Placebo then TRIV-509', 'First TRIV-509 then Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17271', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #11', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #4', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33016', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #3', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #7', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #9', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #6', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #10', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #1', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #20', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #16', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #5', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75254', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #2', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84663', 'city': 'Springville', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #14', 'geoPoint': {'lat': 40.16523, 'lon': -111.61075}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #8', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'L1S 7K8', 'city': 'Ajax', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #13', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #17', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'L2H 1H5', 'city': 'Niagara Falls', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #12', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'M2N 3A6', 'city': 'North York', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #15'}, {'zip': 'K1H 1E4', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #19', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '01135', 'city': 'Kyiv', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '781-472-2230'}], 'facility': 'Triveni Bio Site #18', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'centralContacts': [{'name': 'Study Director Triveni Bio, Inc', 'role': 'CONTACT', 'email': 'clinicaltrials@triveni.bio', 'phone': '17814722230'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Triveni Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}