Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Stopped: The study was terminated early based on disease flare/lack of efficacy in the early phase of the trial.
United States8 participantsStarted 2021-10-13
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participant must be able to understand and provide informed consent and be willing to comply with study procedures and follow up.
✓. Are at least 18 years of age and not older than 70 years of age at screening.
✓. Meet the ACR/EULAR Classification Criteria for IgG4-RD \[30, 31\].
✓. Have active disease based at screening on an IgG4-RD RI ≥4, with disease manifestations in at least two organ systems.
✓. May have newly-diagnosed or relapsing disease at screening. Relapsing disease is defined as IgG4-RD that has previously been in remission but is now active again.
✓. May be on treatment or off treatment for IgG4-RD at the time of screening. If on treatment, must be willing to discontinue those other treatments before the baseline visit.
✓. No history of severe allergic reactions to monoclonal antibodies.
✓. Female participants of childbearing potential must have a negative pregnancy test upon study entry.
Exclusion criteria
What they're measuring
1
The Percent of Participants in Each Cohort Who Experience at Least One Grade 3 or Higher Adverse Event (AE).
Timeframe: Up to Week 48 post treatment initiation
Trial details
NCT IDNCT04918147
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.
✕. Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.)
✕. The following lab values as indicators of hepatic dysfunction:
✕. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN)
✕. Total bilirubin \> two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin \> three times ULN.
✕. Serum albumin \< 2.5 gm/dL.
✕. Evidence of another uncontrolled condition which, in the judgment of the investigator, could interfere with participation in the trial according to the protocol.
✕. Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to treatment allocation/randomization.