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NCT05669014 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT05669014 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 12 participants.
The verdict
NCT05669014, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.
Interventions
- DRUG Placebo
- DRUG Daxdilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2025-07-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05669014
The ClinicalTrials.gov registry entry for NCT05669014 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05669014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05669014 about?
NCT05669014 is a clinical study titled "A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)". The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the ...
What is the current status of trial NCT05669014?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2023-12-04. Estimated completion is 2025-07-02.
What interventions are being tested in trial NCT05669014?
The interventions under investigation include: Placebo (DRUG), Daxdilimab (DRUG).
Who is sponsoring clinical trial NCT05669014?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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