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NCT04972968 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
A Phase 2 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
NCT04972968: Clinical Trial Phase 2 study, sponsored by AbbVie.
NCT04972968 is a Phase 2 study that was terminated before completion, run by AbbVie. The registered enrollment target is 181 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04972968, a Phase 2 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
Study Summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). There may be higher treatment burden for participants in this trial compared to their standard of care. 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.
Primary Outcome
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
Interventions
- DRUG Placebo
- DRUG Glucocorticoid
- DRUG ABBV-154
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2021-09-09 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 2 |
Why NCT04972968 stopped before completion
NCT04972968 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04972968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04972968 about?
NCT04972968 is a clinical study titled "A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154". Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will ...
What is the current status of trial NCT04972968?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2021-09-09. Estimated completion is 2023-07-24.
What interventions are being tested in trial NCT04972968?
The interventions under investigation include: Placebo (DRUG), Glucocorticoid (DRUG), ABBV-154 (DRUG).
Who is sponsoring clinical trial NCT04972968?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04972968's enrollment target sits among peer trials
181 365th of 2000 higher than 1,636 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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