Crohn's Disease Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B. The duration of the study will be approximately 49 weeks.
| Status | Recruiting |
| Enrollment | 276 |
| Est. completion date | February 23, 2028 |
| Est. primary completion date | March 27, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline. - Participant meets the following disease activity criteria: 1. Moderate to severe CD as assessed by CDAI 2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD - Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD. Exclusion Criteria: - Participants with a current diagnosis of ulcerative colitis or indeterminate colitis. - Participants with unstable doses of concomitant Crohn's disease therapy. - Participants with prior exposure to p19 inhibitors. - Participants with complications of Crohn's disease. - Participants having an ostomy or ileoanal pouch. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Digestive Disease Associates, Inc. /ID# 260532 | Vaughan | Ontario |
| Israel | Shaare Zedek Medical Center /ID# 256253 | Jerusalem | Yerushalayim |
| Israel | The Chaim Sheba Medical Center /ID# 256251 | Ramat Gan | Tel-Aviv |
| Japan | Gamagori City Hospital /ID# 261372 | Gamagori-shi | Aichi |
| Japan | Tsujinaka Hospital Kashiwanoha /ID# 261370 | Kashiwa-shi | Chiba |
| Japan | Hyogo Medical University Hospital /ID# 261371 | Nishinomiya-shi | Hyogo |
| Japan | NHO Shizuoka Medical Center /ID# 261373 | Sunto-gun | Shizuoka |
| Korea, Republic of | The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257 | Daejeon | Daejeon Gwang Yeogsi |
| Korea, Republic of | Asan Medical Center /ID# 259255 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Samsung Medical Center /ID# 259254 | Seoul | |
| Korea, Republic of | Yonsei University Health System Severance Hospital /ID# 259256 | Seoul | Seoul Teugbyeolsi |
| Taiwan | Far Eastern Memorial Hospital /ID# 256893 | New Taipei City | |
| Taiwan | China Medical University Hospital /ID# 256890 | Taichung | |
| Taiwan | National Taiwan University Hospital /ID# 256891 | Taipei City | Taipei |
| Taiwan | Linkou Chang Gung Memorial Hospital /ID# 256892 | Taoyuan City | |
| United Kingdom | Whiston Hospital /ID# 261449 | Prescot | |
| United States | Amel Med LLC. /ID# 259642 | Austin | Texas |
| United States | NY Scientific /ID# 261209 | Brooklyn | New York |
| United States | Univ NC Chapel Hill /ID# 256368 | Chapel Hill | North Carolina |
| United States | Clin Res Inst of Michigan, LLC /ID# 256609 | Chesterfield | Michigan |
| United States | Clin Res Inst of Michigan, LLC /ID# 261017 | Chesterfield | Michigan |
| United States | Optimed Research, Ltd. /ID# 256573 | Columbus | Ohio |
| United States | Research Associates of South Florida, LLC /ID# 261627 | Coral Gables | Florida |
| United States | Gastro One /ID# 256614 | Cordova | Tennessee |
| United States | Kindred Medical Institute - Corona /ID# 262075 | Corona | California |
| United States | Southern California Res. Ctr. /ID# 256612 | Coronado | California |
| United States | Atlanta Ctr. for Gastro /ID# 261181 | Decatur | Georgia |
| United States | Allied Health Clinical Research Organization, LLC /ID# 261618 | Englewood | New Jersey |
| United States | Plains Clinical Research Center, LLC /ID# 256602 | Fargo | North Dakota |
| United States | Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596 | Garland | Texas |
| United States | GI Alliance - Glenview /ID# 257744 | Glenview | Illinois |
| United States | Carolina Research /ID# 261435 | Greenville | North Carolina |
| United States | GI Alliance - Gurnee /ID# 257735 | Gurnee | Illinois |
| United States | The Ohio State University - Hilliard /ID# 256623 | Hilliard | Ohio |
| United States | Baylor College of Medicine /ID# 256600 | Houston | Texas |
| United States | Newport Huntington Medical Group /ID# 256622 | Huntington Beach | California |
| United States | Auzmer Research /ID# 261437 | Lakeland | Florida |
| United States | Om Research LLC /ID# 259645 | Lancaster | California |
| United States | University of Louisville Hospital /ID# 256569 | Louisville | Kentucky |
| United States | GI Alliance/TDDC /ID# 261623 | Lubbock | Texas |
| United States | Gastroenterology Associates of Central Georgia, LLC /ID# 256611 | Macon | Georgia |
| United States | Atlantic Medical Research /ID# 256471 | Margate | Florida |
| United States | Homestead Associates in Research /ID# 259643 | Miami | Florida |
| United States | JD Medical Group, LLC /ID# 262185 | Miami | Florida |
| United States | Wisconsin Center for Advanced Research /ID# 256575 | Milwaukee | Wisconsin |
| United States | Gastroenterology Group Naples /ID# 256566 | Naples | Florida |
| United States | Quality Medical Research /ID# 262077 | Nashville | Tennessee |
| United States | New York Gastroenterology Associates /ID# 257730 | New York | New York |
| United States | Hightower Clinical /ID# 256613 | Oklahoma City | Oklahoma |
| United States | Endoscopic Research, Inc. /ID# 256597 | Orlando | Florida |
| United States | Mayo Clinic - Rochester /ID# 256594 | Rochester | Minnesota |
| United States | Gastroenterology Consultants, P.C /ID# 260635 | Roswell | Georgia |
| United States | Southern Star Research Institute, LLC /ID# 256601 | San Antonio | Texas |
| United States | Louisiana Research Center, LLC /ID# 256598 | Shreveport | Louisiana |
| United States | GCP Clinical Research, LLC /ID# 260342 | Tampa | Florida |
| United States | Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592 | Topeka | Kansas |
| United States | Tyler Research Institute, LLC /ID# 256595 | Tyler | Texas |
| United States | GI Alliance Bay Area Gastroenterology /ID# 261866 | Webster | Texas |
| United States | Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568 | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Canada, Israel, Japan, Korea, Republic of, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) | 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 | Week 12 | |
| Primary | Percentage of Participants With Endoscopic Response | The Simple Endoscopic Score for Crohn's Disease (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 (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline) | Week 12 | |
| Secondary | Percentage of Participants With Clinical Remission | Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline. | Week 12 | |
| Secondary | Percentage of Participants With Endoscopic Remission | Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable | Week 12 | |
| Secondary | Percentage of Participants With Ulcer-Free Endoscopy | Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore = 1 at Baseline | Week 12 | |
| Secondary | Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a 5-point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement. | Week 12 | |
| Secondary | Percentage of Participants with a CR-100 Clinical Response | CR-100 defined as at least a 100-point reduction from Baseline in CDAI | Week 4 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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