A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Public ClinicalTrials.gov record NCT06063967. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A 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. In Period C, eligible participants will receive open-label risankizumab SC Dose D. 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 followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Study identification
- NCT ID
- NCT06063967
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 289 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2023 (Actual)
- Primary completion
- Mar 2027 (Estimated)
- Completion
- Mar 2027 (Estimated)
- Last update posted
- Sep 9, 2025
2023 – 2027
United States locations
- U.S. sites
- 79
- U.S. states
- 26
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 | Sun City | Arizona | 85351 | — |
| Kindred Medical Institute - Corona /ID# 262075 | Corona | California | 92879-3104 | — |
| Southern California Res. Ctr. /ID# 256612 | Coronado | California | 92118-1408 | — |
| Valley Clinical Trials, LLC dba Flourish Research /ID# 256610 | Covina | California | 91723 | — |
| Newport Huntington Medical Group /ID# 256622 | Huntington Beach | California | 92648-5994 | — |
| Om Research LLC /ID# 259645 | Lancaster | California | 93534 | — |
| Om Research LLC /ID# 267523 | Lancaster | California | 93534 | — |
| Clinnova Research - Orange /ID# 270138 | Orange | California | 92868 | — |
| University of California, Irvine Medical Center /ID# 259677 | Orange | California | 92868 | — |
| Prospective Research Innovations Inc. /ID# 267856 | Rancho Cucamonga | California | 91730 | — |
| University of California San Francisco - Mission Bay /ID# 267529 | San Francisco | California | 94158 | — |
| Amicis Research Center - Valencia /ID# 269158 | Valencia | California | 91355 | — |
| OM Research LLC /ID# 268735 | Victorville | California | 92395 | — |
| Danbury Hospital, Western Connecticut Health Network /ID# 261851 | Danbury | Connecticut | 06810 | — |
| Novum Research /ID# 269223 | Clermont | Florida | 34711 | — |
| Research Associates of South Florida, LLC /ID# 261627 | Coral Gables | Florida | 33134-2442 | — |
| University of Florida College of Medicine /ID# 261248 | Gainesville | Florida | 32610 | — |
| Auzmer Research /ID# 261437 | Lakeland | Florida | 33813-4924 | — |
| Cfagi Llc /Id# 262005 | Maitland | Florida | 32751-6108 | — |
| Atlantic Medical Research /ID# 256471 | Margate | Florida | 33063-5737 | — |
| Homestead Associates in Research /ID# 259643 | Miami | Florida | 33032 | — |
| University of Miami /ID# 256587 | Miami | Florida | 33136 | — |
| JD Medical Group, LLC /ID# 262185 | Miami | Florida | 33176-2302 | — |
| Gastroenterology Group Naples /ID# 256566 | Naples | Florida | 34102 | — |
| Sarkis Clinical Trials - Ocala /ID# 267840 | Ocala | Florida | 34474 | — |
| Endoscopic Research, Inc. /ID# 256597 | Orlando | Florida | 32803 | — |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811 | Orlando | Florida | 32804-5505 | — |
| GCP Clinical Research, LLC /ID# 260342 | Tampa | Florida | 33609 | — |
| Avita Clinical Research /ID# 261640 | Tampa | Florida | 33613-1825 | — |
| Winship Cancer Institute of Emory University /ID# 261877 | Atlanta | Georgia | 30322 | — |
| Mount Vernon Clinical Research /ID# 271813 | Atlanta | Georgia | 30328 | — |
| Atlanta Ctr. for Gastro /ID# 261181 | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 256611 | Macon | Georgia | 31201 | — |
| Gastroenterology Consultants, P.C /ID# 260635 | Roswell | Georgia | 30076-4913 | — |
| Grand Teton Research Group /ID# 267521 | Idaho Falls | Idaho | 83404 | — |
| Duplicate_The University of Chicago DCAM /ID# 256577 | Chicago | Illinois | 60637 | — |
| GI Alliance - Glenview /ID# 257744 | Glenview | Illinois | 60026-8000 | — |
| GI Alliance - Gurnee /ID# 257735 | Gurnee | Illinois | 60031-5711 | — |
| Southwest Gastroenterology /ID# 256619 | Oak Lawn | Illinois | 60453 | — |
| IU Health University Hospital /ID# 259633 | Indianapolis | Indiana | 46202-5149 | — |
| Univ Kansas Med Ctr /ID# 262551 | Kansas City | Kansas | 66160 | — |
| Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592 | Topeka | Kansas | 66606 | — |
| University of Louisville Hospital /ID# 256569 | Louisville | Kentucky | 40202 | — |
| Louisiana Research Center, LLC /ID# 256598 | Shreveport | Louisiana | 71105-6800 | — |
| Portland Gastroenterology Center - Portland - Congress Street /ID# 268428 | Portland | Maine | 04102 | — |
| Massachusetts General Hospital /Id# 261051 | Boston | Massachusetts | 02114 | — |
| Clin Res Inst of Michigan, LLC /ID# 256609 | Chesterfield | Michigan | 48047 | — |
| Clin Res Inst of Michigan, LLC /ID# 261017 | Chesterfield | Michigan | 48047 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 256594 | Rochester | Minnesota | 55905-0001 | — |
| Saint Lukes Hospital of Kansas City /ID# 271816 | Kansas City | Missouri | 64111 | — |
| Allied Health Clinical Research Organization, LLC /ID# 261618 | Englewood | New Jersey | 07631-4152 | — |
| NY Scientific /ID# 261209 | Brooklyn | New York | 11235-3919 | — |
| Columbia University Medical Center /ID# 261879 | New York | New York | 10032-3729 | — |
| New York Gastroenterology Associates /ID# 257730 | New York | New York | 10075 | — |
| Univ NC Chapel Hill /ID# 256368 | Chapel Hill | North Carolina | 27514-4220 | — |
| Carolina Research /ID# 261435 | Greenville | North Carolina | 27834 | — |
| Boice-Willis Clinic, P.A. /ID# 262209 | Rocky Mount | North Carolina | 27804 | — |
| Plains Clinical Research Center, LLC /ID# 256602 | Fargo | North Dakota | 58104-5925 | — |
| Optimed Research, Ltd. /ID# 256573 | Columbus | Ohio | 43235 | — |
| The Ohio State University - Hilliard /ID# 256623 | Hilliard | Ohio | 43210 | — |
| Hightower Clinical /ID# 256613 | Oklahoma City | Oklahoma | 73102 | — |
| Options Health Research /ID# 271243 | Tulsa | Oklahoma | 74104 | — |
| Gastro One /ID# 256614 | Cordova | Tennessee | 38018 | — |
| Quality Medical Research /ID# 262077 | Nashville | Tennessee | 37211 | — |
| Amel Med LLC. /ID# 259642 | Austin | Texas | 78705 | — |
| Novel Research - Bellaire /ID# 269788 | Bellaire | Texas | 77401 | — |
| University of Texas - Southwestern Medical Center /ID# 268157 | Dallas | Texas | 75235 | — |
| Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596 | Garland | Texas | 75044 | — |
| Baylor College of Medicine /ID# 256600 | Houston | Texas | 77030 | — |
| LinQ Research /ID# 267880 | Houston | Texas | 77087 | — |
| GI Alliance/TDDC /ID# 261623 | Lubbock | Texas | 79410-2014 | — |
| North Hills Medical Research - North Richard Hills /ID# 268411 | North Richland Hills | Texas | 76180 | — |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 256599 | San Antonio | Texas | 78212 | — |
| Southern Star Research Institute, LLC /ID# 256601 | San Antonio | Texas | 78229-5390 | — |
| Tyler Research Institute, LLC /ID# 256595 | Tyler | Texas | 75701 | — |
| GI Alliance Bay Area Gastroenterology /ID# 261866 | Webster | Texas | 77598-4052 | — |
| University Physicians and Surgeons Inc. /ID# 259636 | Huntington | West Virginia | 25701 | — |
| Wisconsin Center for Advanced Research /ID# 256575 | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06063967, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06063967 live on ClinicalTrials.gov.