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NCT04999020 · ClinicalTrials.gov registry record · Phase 2
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT04999020: Clinical Trial Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT04999020 is a Phase 2 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04999020, a Phase 2 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).
Primary Outcome
Data are presented for the number of participants with a TIS40 response, defined as an IMACS-TIS score ≥ 40 at Week 26. IMACS-TIS is a clinical instrument that encompasses 6 core set measure (CSMs) (physician, patient, extra-muscular global activity, muscle strength, Health Assessment Questionnaire \[HAQ\], and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. A higher sco
Interventions
- DRUG Placebo
- DRUG Ravulizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 2 |
Why NCT04999020 stopped before completion
NCT04999020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04999020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04999020 about?
NCT04999020 is a clinical study titled "Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis". This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).
What is the current status of trial NCT04999020?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-11-19. Estimated completion is 2024-05-08.
What interventions are being tested in trial NCT04999020?
The interventions under investigation include: Placebo (DRUG), Ravulizumab (DRUG).
Who is sponsoring clinical trial NCT04999020?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04999020's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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