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Monoclonal Antibodies

Elotuzumab for IgG4-Related Disease

Q: What therapeutic uses has elotuzumab been demonstrated to have?

<p>elotuzumab is traditionally employed to address <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, but it has been seen as an effective treatment for a variety of other afflictions such as <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, varicella-zoster virus acute retinal necrosis and tuberculous meningitis.</p>

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 48

Awards & highlights

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.

Who is the study for?

Adults aged 18-70 with active IgG4-Related Disease, meeting specific disease criteria and vaccinated against COVID-19. Participants must not have severe allergies to monoclonal antibodies or be pregnant, and should agree to use effective birth control.Check my eligibility

What is being tested?

The trial is testing elotuzumab's safety in Part 1 and its effectiveness compared to a placebo in Part 2 when both are combined with prednisone for treating IgG4-RD. It's a multi-center study involving about 75 participants over approximately 11 months.See study design

What are the potential side effects?

Possible side effects include allergic reactions related to monoclonal antibodies like elotuzumab, as well as those associated with steroids such as prednisone (e.g., weight gain, high blood pressure). Specific side effects of elotuzumab will be determined during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants in Cohort 2: Percent Change in Immunoglobulin G4-Related Disease Responder Index (IgG4-RD RI) Score

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

Secondary outcome measures

Change from Baseline in Patient Global Assessment (PGA)-By Cohort Group

Change from Baseline in Physician Global Assessment (PhGA)-By Cohort Group

Number of Immunoglobulin G4-Related Disease (IgG4-RD) Flares by Cohort Group by Week 48

+11 more

Side effects data

From 2016 Phase 2 trial • 101 Patients • NCT00742560

67%

NEUTROPENIA

67%

CHILLS

67%

INSOMNIA

67%

ANAEMIA

33%

THROMBOCYTOPENIA

33%

TINNITUS

33%

LEUKOPENIA

33%

CONSTIPATION

33%

FATIGUE

33%

SINUSITIS

33%

RHINITIS

33%

BALANCE DISORDER

33%

PARAESTHESIA

33%

DEPRESSION

33%

PRURITUS

33%

DEEP VEIN THROMBOSIS

33%

RASH

33%

MUSCLE SPASMS

33%

RASH GENERALISED

33%

DIARRHOEA

33%

PAIN IN JAW

33%

HEADACHE

33%

VERTIGO

100%

80%

60%

40%

20%

Study treatment Arm

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: Arm A- Elotuzumab (Randomized) + Pred TaperExperimental Treatment6 Interventions

Safety and efficacy analyses from Cohort 1a and Cohort 1b will occur prior to initiating Cohort 2 (Randomized). Assuming no safety signal for Cohort 1, forty-two participants will receive elotuzumab per the regimen prescribed above in Part 1B, with the prescribed 10-week prednisone taper. Elotuzumab: 10 mg/kg administered as referenced above, intravenously, per protocol. Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 that is taken daily by mouth, per protocol. Dosage in milligrams (mgs).

Group II: Cohort 1b: Elotuzumab-Twelve-Month Regimen (Open-Label) + Pred TaperExperimental Treatment6 Interventions

Per protocol: Six participants will receive elotuzumab over a 48 week period, dose of 10mg/kg IV x 1, at baseline, then at weeks 8, 16, 24, 32 and 40 (for a total of 6 doses), with the prescribed 10-week prednisone taper. Elotuzumab: 10 mg/kg administered as referenced above, intravenously, per protocol. Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 (baseline) that is taken orally (by mouth) daily, per protocol. Dosage in milligrams (mgs).

Group III: Cohort 1a: Elotuzumab-One-Month Regimen (Open-Label) + Pred TaperExperimental Treatment6 Interventions

Per protocol: Six participants will receive elotuzumab on days 0,7, 14, 21, and the prescribed 10-week prednisone taper. Elotuzumab: 10 mg/kg administered once weekly, intravenously for 4 doses, per protocol. Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 (baseline) that is taken orally (by mouth) daily, per protocol. Dosage in milligrams (mgs).

Group IV: Cohort 2: Arm B-Placebo (Randomized) + Pred TaperPlacebo Group6 Interventions

Safety and efficacy analyses from Cohort 1a and Cohort 1b will occur prior to initiating Cohort 2 (Randomized). Twenty-one participants will receive placebo for elotuzumab on day 0, then weeks 8, 16, 24, 32 and 40, and the prescribed 10-week prednisone taper. Placebo for elotuzumab: Administered on same schedule as elotuzumab described in Cohort 2 Arm A: intravenously, per protocol. Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 taken daily by mouth, per protocol. Dosage in milligrams (mgs).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

acetaminophen

2008

Completed Phase 4

~2870

diphenhydramine

2011

Completed Phase 4

~420

elotuzumab

2008

Completed Phase 3

~720

famotidine

2019

Completed Phase 4

~4239010

prednisone

1999

Completed Phase 3

~10920

methylprednisolone

2004

Completed Phase 4

~1050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rho Federal Systems Division, Inc.Industry Sponsor

40 Previous Clinical Trials

13,555 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,124 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,506 Total Patients Enrolled

Media Library

Related Disease Research Study Groups: Cohort 1a: Elotuzumab-One-Month Regimen (Open-Label) + Pred Taper, Cohort 1b: Elotuzumab-Twelve-Month Regimen (Open-Label) + Pred Taper, Cohort 2: Arm A- Elotuzumab (Randomized) + Pred Taper, Cohort 2: Arm B-Placebo (Randomized) + Pred Taper

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has elotuzumab received authorization from the Food and Drug Administration?

"Based on our assessment, elotuzumab receives safety rating of 2 since Phase 2 trials provide evidence that the medication is safe but do not yet show efficacy."

Answered by AI

What core aims does this investigation seek to achieve?

"The primary aim of this medical experiment, with data collection at Week 24 post treatment commencement, is to determine how many participants in Cohort 2 experience a change in Immunoglobulin G4-Related Disease Responder Index (IgG4-RD RI) Score. Additional objectives include calculating the proportion of patients who demonstrate an improvement in IgG4-RD Responder Index (IgG4-RD RI), ascertaining the number of Immunoglobulin G4-Related Disease (IgG4-RD) Flares by cohort group by Week 24 and establishing what percentage endure infusion reactions that are Grade 2 or higher"

Answered by AI

What therapeutic uses has elotuzumab been demonstrated to have?

"elotuzumab is traditionally employed to address pain, but it has been seen as an effective treatment for a variety of other afflictions such as ulcerative colitis, varicella-zoster virus acute retinal necrosis and tuberculous meningitis."

Answered by AI

Has there been any other research conducted on the efficacy of elotuzumab?

"At present, there are 528 ongoing clinical trials related to elotuzumab, of which 143 are in the final phase. Most experiments centered around this treatment take place in New york City; however, 18839 other locations across the world also host studies with elotuzumab."

Answered by AI

Am I a suitable candidate for this clinical investigation?

"This clinical trial is searching for 75 volunteers who meet the criteria of IgG4-RD, aged between 18 and 70. These individuals should have either newly diagnosed or recurrent symptoms at screening; no history of acute hypersensitivity to monoclonal antibodies; female participants must provide a negative pregnancy test before enrollment; those on medication need to cease consumption prior to baseline visit and can be off treatment or undergoing current treatments during screening."

Answered by AI

Is the age limit for this medical trial greater than 75 years?

"The eligibility criteria for this clinical trial dictates that participants must be between 18 and 70 years of age."

Answered by AI

How many participants have been recruited for this research?

"Rho Federal Systems Division, Inc. will be ensuring the successful conduction of this trial from Massachusetts General Hospital in Boston and Mayo Clinic: Pulmonary and Critical Care Medicine in Rochester. To get going on the study, 75 qualified individuals are necessary to fulfill inclusion criteria."

Answered by AI

Are there currently any opportunities for qualifying patients to participate in this clinical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research project was posted initially on October 13th 2021 and recently updated on July 13th 2022. The trial requires 75 participants from 3 separate medical centres in order to be completed successfully."

Answered by AI

Recent research and studies

Annals of the Rheumatic DiseasesJournal

The 2019 American College of Rheumatology/european League Against Rheumatism Classification Criteria for Igg4-related Disease

Wallace, Zachary S, Ray P Naden, Suresh Chari, Hyon K Choi, Emanuel Della-Torre, Jean-Francois Dicaire, Phillip A Hart, et al.. 2019. “The 2019 American College of Rheumatology/european League Against Rheumatism Classification Criteria for Igg4-related Disease”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2019-216561.

Arthritis & RheumatologyJournal

International Consensus Guidance Statement on the Management and Treatment of Igg4-related Disease

Khosroshahi, A., Z. S. Wallace, J. L. Crowe, T. Akamizu, A. Azumi, M. N. Carruthers, S. T. Chari, et al.. 2015. “International Consensus Guidance Statement on the Management and Treatment of Igg4-related Disease”. Arthritis & Rheumatology. Wiley. doi:10.1002/art.39132.

clinicaltrials.govStudy

Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

2021. "Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04918147.