Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Purpose

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.

Condition

  • Crohn's Disease

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Monotherapy: Risankizumab 		Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.
  • Drug: Risankizumab
    Subcutaneous Injection
  • Drug: Risankizumab
    Intravenous Infusion
Experimental
Combination Therapy: Risankizumab and 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.
  • Drug: Risankizumab
    Subcutaneous Injection
  • Drug: ABBV-382
    Intravenous Infusion
  • Drug: Risankizumab
    Intravenous Infusion
  • Drug: ABBV-382
    Subcutaneous Injection
Experimental
Monotherapy: ABBV-382 		Participants will receive ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.
  • Drug: ABBV-382
    Intravenous Infusion
  • Drug: ABBV-382
    Subcutaneous Injection
Experimental
Combination Therapy: Risankizumab and 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.
  • Drug: Risankizumab
    Subcutaneous Injection
  • Drug: Lutikizumab
    Subcutaneous Injection
  • Drug: Risankizumab
    Intravenous Infusion
Experimental
Monotherapy: Lutikizumab 		Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.
  • Drug: Lutikizumab
    Subcutaneous Injection
Experimental
Long-Term Extension: Risankizumab Monotherapy 		Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.
  • Drug: Risankizumab
    Subcutaneous Injection
  • Drug: Risankizumab
    Intravenous Infusion

Recruiting Locations

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com