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NCT04918147 · ClinicalTrials.gov registry record · Phase 2
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04918147: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04918147 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04918147, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a two-part multi-center clinical trial in participants with active IgG4-RD. Part 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the safety of elotuzumab for investigation in IgG4-RD. Part 2 (Cohort 2) is a randomized, placebo-controlled, double-blinded (masked) trial phase to compare the effects of elotuzumab and prednisone to elotuzumab placebo and prednisone in participants with IgG4 RD. Approximately 75 participants with active IgG4-RD will be enrolled in the overall program, 12 in Part 1 and 63 in Part 2. Randomization in Part 2: 2 to 1, with approximately forty-two participants randomized to elotuzumab plus prednisone taper, and twenty-one participants randomized to placebo for elotuzumab plus prednisone taper. The total duration of participation for each participant in this trial will be 48 weeks (11 months).
Primary Outcome
The severity of AEs were classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
Interventions
- DRUG methylprednisolone
- DRUG acetaminophen
- DRUG diphenhydramine
- DRUG elotuzumab
- DRUG placebo for elotuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2024-01-04 |
| Phase | Phase 2 |
Why NCT04918147 stopped before completion
NCT04918147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.
NCT04918147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04918147 about?
NCT04918147 is a clinical study titled "Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)". This is a two-part multi-center clinical trial in participants with active IgG4-RD. Part 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the safety of elotuzumab for investigation in IgG4-RD. Part 2 (Cohort 2) is a randomized, placebo-controlled, double-blinded (ma...
What is the current status of trial NCT04918147?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2021-10-13. Estimated completion is 2024-01-04.
What interventions are being tested in trial NCT04918147?
The interventions under investigation include: methylprednisolone (DRUG), acetaminophen (DRUG), diphenhydramine (DRUG), elotuzumab (DRUG), placebo for elotuzumab (DRUG).
Who is sponsoring clinical trial NCT04918147?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04918147's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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