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NCT05068284 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease
A Phase 2 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
NCT05068284 is a Phase 2 study that was terminated before completion, run by AbbVie. The registered enrollment target is 176 participants.
The verdict
NCT05068284, a Phase 2 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
Study Summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. 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, checking for side effects and completing questionnaires.
Interventions
- DRUG Placebo
- DRUG ABBV-154
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2023-07-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05068284
The ClinicalTrials.gov registry entry for NCT05068284 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05068284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05068284 about?
NCT05068284 is a clinical study titled "A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease". Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for modera...
What is the current status of trial NCT05068284?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2022-01-31. Estimated completion is 2023-07-20.
What interventions are being tested in trial NCT05068284?
The interventions under investigation include: Placebo (DRUG), ABBV-154 (DRUG).
Who is sponsoring clinical trial NCT05068284?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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