Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Registration Number
- NCT06548542
- Lead Sponsor
- AbbVie
- Brief Summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Participants' 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.
- Participants must demonstrate intolerance or inadequate response to TaTs including biologics
- Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- Participant 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.
- Participant 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
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy: Risankizumab Risankizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection. Monotherapy: Lutikizumab Lutikizumab Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection. Long-Term Extension: Risankizumab Monotherapy Risankizumab Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks. Combination Therapy: Risankizumab and ABBV-382 Risankizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection. Monotherapy: ABBV-382 ABBV-382 Participants will receive ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection. Combination Therapy: Risankizumab and ABBV-382 ABBV-382 Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection. Combination Therapy: Risankizumab and Lutikizumab Risankizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection. Combination Therapy: Risankizumab and Lutikizumab Lutikizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve Endoscopic Remission Week 12 The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) Week 12 The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150
Percentage of Participants who Achieve Endoscopic Response Week 12 The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD ≥ 50% from Baseline, as scored by central reader.
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS) Week 12 SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
Trial Locations
- Locations (221)
Digestive Health Specialists /ID# 266216
🇺🇸Dothan, Alabama, United States
East View Medical Research /ID# 270377
🇺🇸Mobile, Alabama, United States
Southern California Res. Ctr /ID# 265549
🇺🇸Coronado, California, United States
UC San Diego Health System /ID# 265565
🇺🇸La Jolla, California, United States
uc davis medical center - patient support services building /ID# 265554
🇺🇸Sacramento, California, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
🇺🇸San Diego, California, United States
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
🇺🇸Colorado Springs, Colorado, United States
Danbury Hospital, Western Connecticut Health Network /ID# 265556
🇺🇸Danbury, Connecticut, United States
Yale University School of Medicine /ID# 266786
🇺🇸New Haven, Connecticut, United States
Nature Coast Clinical Research - Inverness /ID# 265874
🇺🇸Inverness, Florida, United States
Scroll for more (211 remaining)Digestive Health Specialists /ID# 266216🇺🇸Dothan, Alabama, United States