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Monoclonal Antibodies

Targeted Therapies for Crohn's Disease (Target CD Trial)

Phase 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Participants' body weight must be ≥ 40 kg at Baseline.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

No Placebo-Only Group

Summary

"This trial will evaluate the effectiveness and side effects of targeted therapies for adults with moderate to severe Crohn's disease. The study will involve three medicines - risankizumab, ABBV-

Who is the study for?

Adults with moderate to severe Crohn's Disease who weigh at least 40 kg and have been diagnosed for over 3 months. They must show intolerance or inadequate response to existing targeted therapies, have a certain level of disease activity, and evidence of inflammation in the bowels.

What is being tested?

The trial is testing three drugs: Risankizumab, ABBV-382, and Lutikizumab. Participants will be randomly assigned to one of these treatments and monitored over a period that includes induction (12 weeks), maintenance (12 weeks), and possibly an extension phase.

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infection due to immune system suppression by the drugs, allergic reactions, gastrointestinal symptoms like nausea or abdominal pain, headaches, fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is at least 40 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Achieve Endoscopic Remission

Secondary study objectives

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)

Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)

Percentage of Participants who Achieve Endoscopic Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Monotherapy: RisankizumabExperimental Treatment1 Intervention

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.

Group II: Monotherapy: LutikizumabExperimental Treatment1 Intervention

Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.

Group III: Monotherapy: ABBV-382Experimental Treatment1 Intervention

Participants will receive ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.

Group IV: Long-Term Extension: Risankizumab MonotherapyExperimental Treatment1 Intervention

Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.

Group V: Combination Therapy: Risankizumab and LutikizumabExperimental Treatment2 Interventions

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.

Group VI: Combination Therapy: Risankizumab and ABBV-382Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3340

ABBV-382

2021

Completed Phase 1

~60