Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:23 AM
Study NCT ID:
NCT07403968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs)', 'timeFrame': 'From start of study drug administration up to follow-up (up to Week 16)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency after exposure to the trial intervention. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/d26b38ab4fa04132??page=1&idFilter=TAK-279-CD-2003', 'label': 'Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.'}, {'url': 'https://clinicaltrials.takeda.com/?chat=true', 'label': "Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language."}]}, 'descriptionModule': {'briefSummary': "Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is.\n\nThe participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy.\n\nDuring the study, participants will visit the study clinic several times.", 'detailedDescription': "Zasocitinib will be tested in this mechanistic study in adult participants with active Crohn's disease (CD). Peripheral blood and affected intestinal biopsy samples will be evaluated at the cellular and molecular levels, before and during zasocitinib treatment. The study will assess therapeutic biology, biomarkers, and the safety of zasocitinib.\n\nThe study will enroll approximately 20 participants. This is a single center study. The overall duration is up to approximately 5 months (20 weeks) including a 4-week safety follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women aged 18 to 75 years can participate in the study.\n2. Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.\n3. Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.\n\nExclusion Criteria\n\n1. Cannot have another condition that causes swelling (inflammation) in the bowel.\n2. Cannot have complications of CD which may require surgery.\n3. Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.\n4. Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.\n5. Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.\n6. Cannot have or had a J-pouch.\n7. Cannot have had infections up to 2 months (8 weeks) before study start.\n8. Cannot have given blood or plasma within 1 month (30 days) before study start.\n9. Cannot tolerate having blood taken with a needle from a vein (venipuncture).\n\nAdditional entry criteria will be discussed with the study doctor."}, 'identificationModule': {'nctId': 'NCT07403968', 'briefTitle': "A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'TAK-279-CD-2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zasocitinib Dose', 'description': 'Participants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12).', 'interventionNames': ['Drug: Zasocitinib']}], 'interventions': [{'name': 'Zasocitinib', 'type': 'DRUG', 'otherNames': ['TAK-279'], 'description': 'Zasocitinib administered orally.', 'armGroupLabels': ['Zasocitinib Dose']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Takeda Contact', 'role': 'CONTACT', 'email': 'medinfoUS@takeda.com', 'phone': '+1-877-825-3327'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}