Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Part of paid clinical trials in Lakeland, Florida.

Sponsor
AbbVie
Study ID
NCT07697456
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Risankizumab — DRUG
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
  • Trosunilimab — DRUG
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion
  • ABBV-701 — DRUG
    Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 24, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: UC Arm 1 Risankizumab monotherapy
    Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
  • Experimental: Substudy 1: CD Arm 1 Risankizumab monotherapy
    Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
  • Experimental: Substudy 1: UC Arm 2 Trosunilimab monotherapy
    Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.
  • Experimental: Substudy 1: CD Arm 2 Trosunilimab monotherapy
    Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.
  • Experimental: Substudy 1: UC Arm 3 Trosunilimab monotherapy
    Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.
  • Experimental: Substudy 1: CD Arm 3 Trosunilimab monotherapy
    Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.
  • Experimental: Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
    Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C
  • Experimental: Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
    Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D
  • Experimental: Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
    Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G
  • Experimental: Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
    Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H
  • Experimental: Substudy 2: UC Arm 1 Risankizumab monotherapy
    Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
  • Experimental: Substudy 2: CD Arm 1 Risankizumab monotherapy
    Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
  • Experimental: Substudy 2: UC Arm 2 ABBV-701 monotherapy
    Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.
  • Experimental: Substudy 2: CD Arm 2 ABBV-701 monotherapy
    Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.
  • Experimental: Substudy 2: UC Arm 3 ABBV-701 monotherapy
    Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.
  • Experimental: Substudy 2: CD Arm 3 ABBV-701 monotherapy
    Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.
  • Experimental: Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
    Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C.
  • Experimental: Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
    Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D.
  • Experimental: Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
    Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G.
  • Experimental: Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
    Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H.
  • Experimental: Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
    Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J
  • Experimental: Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
    Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L

Primary Outcome Measure

Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: At Week 28 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Auzmer Research /ID# 280786LakelandFlorida33813-
Gastro Health - Miami /ID# 282001MiamiFlorida33176-
Portland Gastroenterology Center - Portland - Congress Street /ID# 281970PortlandMaine04102-
Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865HackensackNew Jersey07601-
Queens Village Primary Medical Center /ID# 281857New YorkNew York11428-
Digestive Disease Consultants - Brunswick /ID# 283935BrunswickOhio44212-
Skyline Gastroenterology of West Tennessee /ID# 284146JacksonTennessee38301-
Texas Digestive Disease Consultants /ID# 284159AustinTexas78731-
Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947San MarcosTexas78666-

Find similar trials in Lakeland, FL

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Auzmer Research· Lakeland, FLGastro Health - Miami· Miami, FLPortland Gastroenterology Center - Portland - Congress Street· Portland, MEHackensack Meridian Health - Hackensack University Medical Center· Hackensack, NJQueens Village Primary Medical Center· New York, NYDigestive Disease Consultants - Brunswick· Brunswick, OH

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