elotuzumab for IgG4-RD

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
IgG4-RD+6 More
elotuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is two-part, open-label, and placebo-controlled to study the safety and efficacy of elotuzumab in participants with active IgG4-RD.

Eligible Conditions
  • IgG4-RD
  • IgG4 Related Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Baseline, Weeks 1, 5, 9, 16, 24, and 48

Week 24
Participants in Cohort 2: Percent Change in Immunoglobulin G4-Related Disease Responder Index (IgG4-RD RI) Score
Week 1
Change from Baseline in Patient Global Assessment (PGA)-By Cohort Group
Change from Baseline in Physician Global Assessment (PhGA)-By Cohort Group
Hour 24
Proportion of Participants by Cohort Group who Experience Infusion Reactions
Week 24
Number of Immunoglobulin G4-Related Disease (IgG4-RD) Flares by Cohort Group by Week 24
Proportion of Participants in Cohort 1a Who Experience at Least One Grade 3 or Higher Adverse Event
Proportion of Participants in Cohort 1b Who Experience at Least One Grade 3 or Higher Adverse Event
Week 48
Number of Immunoglobulin G4-Related Disease (IgG4-RD) Flares by Cohort Group by Week 48
Proportion of Participants by Cohort Group who Experience a Hepatotoxicity
Proportion of Participants by Cohort Group who Experience a Malignancy
Proportion of Participants by Cohort Group who Experience a Serious Adverse Event
Proportion of Participants by Cohort Group who Experience at Least One Grade 2 or Higher Adverse Event
Proportion of Participants by Cohort Group with a Grade 3 or Higher Infection
Proportion of Participants in Cohort 2 who Experience at Least One Grade 3 or Higher Adverse Event
Week 24
Proportion of Participants by Cohort Group who Achieve ≥50 Percent (%) Improvement in IgG4-RD Responder Index (IgG4-RD RI) Score at Week 24
Proportion of Participants by Cohort Group who Achieve ≥75 Percent (%) Improvement in IgG4-RD Responder Index (IgG4-RD RI) Score at Week 24
Proportion of Participants by Cohort Group with Disease-Related Damage at Week 24
Proportion of Participants in Cohort 2 in Complete Remission at Week 24

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
67%CHILLS
67%NEUTROPENIA
67%INSOMNIA
67%ANAEMIA
33%THROMBOCYTOPENIA
33%RHINITIS
33%FATIGUE
33%CONSTIPATION
33%DIARRHOEA
33%SINUSITIS
33%MUSCLE SPASMS
33%PAIN IN JAW
33%BALANCE DISORDER
33%HEADACHE
33%PARAESTHESIA
33%DEPRESSION
33%RASH GENERALISED
33%RASH
33%PRURITUS
33%DEEP VEIN THROMBOSIS
33%TINNITUS
33%LEUKOPENIA
33%VERTIGO
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT00742560) in the Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) ARM group. Side effects include: CHILLS with 67%, NEUTROPENIA with 67%, INSOMNIA with 67%, ANAEMIA with 67%, THROMBOCYTOPENIA with 33%.

Trial Design

4 Treatment Groups

Cohort 1b: Elotuzumab-Three-Month Regimen (Open-Label) + Pred Taper
1 of 4
Cohort 1a: Elotuzumab-One-Month Regimen (Open-Label) + Pred Taper
1 of 4
Cohort 2: Arm A- Elotuzumab (Randomized) + Pred Taper
1 of 4
Cohort 2: Arm B-Placebo (Randomized) + Pred Taper
1 of 4
Experimental Treatment
Non-Treatment Group

75 Total Participants · 4 Treatment Groups

Primary Treatment: elotuzumab · Has Placebo Group · Phase 2

Cohort 1b: Elotuzumab-Three-Month Regimen (Open-Label) + Pred TaperExperimental Group · 6 Interventions: methylprednisolone, diphenhydramine, elotuzumab, acetaminophen, famotidine, prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Cohort 1a: Elotuzumab-One-Month Regimen (Open-Label) + Pred TaperExperimental Group · 6 Interventions: methylprednisolone, diphenhydramine, elotuzumab, acetaminophen, famotidine, prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Cohort 2: Arm A- Elotuzumab (Randomized) + Pred TaperExperimental Group · 6 Interventions: methylprednisolone, diphenhydramine, elotuzumab, acetaminophen, famotidine, prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Cohort 2: Arm B-Placebo (Randomized) + Pred TaperPlaceboComparator Group · 6 Interventions: methylprednisolone, diphenhydramine, placebo for elotuzumab, acetaminophen, famotidine, prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone hemisuccinate
FDA approved
Diphenhydramine
FDA approved
Elotuzumab
FDA approved
Acetaminophen
FDA approved
Famotidine
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, weeks 1, 5, 9, 16, 24, and 48

Who is running the clinical trial?

Autoimmunity Centers of ExcellenceOTHER
22 Previous Clinical Trials
3,479 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,127 Previous Clinical Trials
5,060,896 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
38 Previous Clinical Trials
15,156 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,797 Total Patients Enrolled
John H. Stone, MD, MPHStudy ChairMassachusetts General Hospital
2 Previous Clinical Trials
378 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
This is a classification system for IgG4-related disease, which is a recently recognized disorder that affects multiple organ systems
The person has active disease and based on their IgG4-RD Responder Index (RI) ≥4, the disease is manifesting in at least two organ systems.
The individual may have a newly diagnosed or relapsing disease at the screening.
this definition does not include patients with newly diagnosed IgG4-RD
No recorded history of severe allergic reactions associated with monoclonal antibodies.
a negative pregnancy test must be obtained at each study visit
must agree not to participate in this study if they are pregnant or become pregnant during the study
--you will be asked to stop taking any other medications you are taking for at least 7 days before the Baseline visit.
The participant in the study must be able to understand the study procedures and give informed consent, and be willing to comply with study procedures and follow up.
The person may be on treatment or off treatment for IgG4-RD at the time of screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.