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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04918147
The ClinicalTrials.gov registry entry for NCT04918147 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.
NCT04918147 reports 0 study locations.
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.
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