Study of Targeted Therapies for the Treatment of Adult Participants with Moderate to Severe Crohn’s Disease
- Conditions
- Moderate to Severe Crohn’s Disease
- Registration Number
- 2024-513009-30-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
The objective is to evaluate the safety and efficacy and to assess the mechanistic profile of studied targeted therapies (TaTs)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 572
Adults 18 to ≤ 75 years old (subjects must also meet the legal age of majority per local law).
Subjects' body weight must be ≥ 40 kg at Baseline.
Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
CDAI ≥ 220 at Baseline.
Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
Subjects must demonstrate intolerance or inadequate response to 1 or more of the following categories of drugs: oral locally acting steroids, systemic steroids (prednisone or equivalent), immunomodulators, and/or TaTs.
Subjects who demonstrated intolerance to p19 inhibitors, including risankizumab.
Subject who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
Subjects who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of endoscopic remission at Week 12. Achievement of endoscopic remission at Week 12.
- Secondary Outcome Measures
Name Time Method Clinical remission per Crohn's disease activity index (CDAI) at Week 12. Clinical remission per Crohn's disease activity index (CDAI) at Week 12.
Clinical remission per stool frequency (SF)/abdominal pain score (APS) at Week 12. Clinical remission per stool frequency (SF)/abdominal pain score (APS) at Week 12.
Endoscopic response at Week 12. Endoscopic response at Week 12.
Trial Locations
- Locations (140)
University Hospital St Marina Varna
🇧🇬Varna, Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
🇧🇬Sofia, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD
🇧🇬Sofiya, Bulgaria
Medicinski Centar Doverie AD
🇧🇬Sofia, Bulgaria
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
Military Medical Academy
🇧🇬Sofiya, Bulgaria
Second Multiprofile Hospital For Active Treatment Sofia EAD
🇧🇬Sofia, Bulgaria
Opca Bolnica Zadar
🇭🇷Zadar, Croatia
KBC Zagreb
🇭🇷Grad Zagreb, Croatia
Scroll for more (130 remaining)University Hospital St Marina Varna🇧🇬Varna, BulgariaAntonia AtanassovaSite contact+359898346321aniatanassova@abv.bg