NCT07697456 · AbbVie
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
What this study is about
Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss.
View original scientific description
Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. 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, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Interventions
DRUG
Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
DRUG
Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
DRUG
ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Primary outcome measures
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Time frame: At Week 28
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
Time frame: At Week 28
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Number of Participants with Adverse Events (AEs)
Time frame: Up to 98 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- CD specific:
- Crohn's Disease Activity Index (CDAI) score of ≥ 220
- Confirmed diagnosis of CD at least 90 days prior to Baseline
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
- Demonstrated failure of 1 or more therapy for CD UC specific:
- Confirmed diagnosis of UC at least 90 days prior to Baseline
- Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
- Demonstrated failure of 1 or more therapy for UC
Exclusion criteria
- Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
- Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
- Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
- Participants with surgical bowel resection within the past 3 months prior to Baseline CD specific:
- Participants with \>3 prior bowel resections
- Participants with previous small bowel resection(s) of combined length \>100 cm UC specific:
- Participants with prior colectomy (total or subtotal)
- Participants with extent of disease limited to \< 10 cm of rectum
Where
- Dothan, Alabama
- Phoenix, Arizona
- Anaheim, California
- Lancaster, California
- Los Alamitos, California
- Rialto, California
- Colorado Springs, Colorado
- Kissimmee, Florida
- Miami, Florida
- New Port Richey, Florida
- Macon, Georgia
- Roswell, Georgia
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations