What side effects are associated with this type of intervention?

Elotuzumab, a monoclonal antibody targeting SLAMF7, has been associated with side effects such as neutropenia, lymphocytopenia, and increased rates of infections, including herpes zoster. Similar treatments like daratumumab have shown higher rates of overall infections and pneumonia, while rituximab has been linked to infusion reactions and serum-sickness-like reactions. These side effects highlight the importance of monitoring immune function and managing infections in patients receiving these therapies.

What prior FDA approvals exist?

Elotuzumab is a monoclonal antibody targeting SLAMF7, primarily used in multiple myeloma. Similar FDA-approved treatments for immune modulation include daratumumab and isatuximab, both of which are anti-CD38 monoclonal antibodies used in multiple myeloma. These therapies work by targeting specific proteins on the surface of immune cells to modulate the immune response. While specific FDA approvals for IgG4-RD are not detailed, the use of monoclonal antibodies like elotuzumab in clinical trials suggests a growing interest in immune-modulating therapies for related diseases.

What other types of research exist?

Promising novel alternatives to Elotuzumab for IgG4-Related Disease patients in 2024 include: <ol> <li>Rituximab: A monoclonal antibody targeting CD20, used in various autoimmune diseases and showing potential in IgG4-RD.</li> <li></li> </ol> Tocilizumab: An IL-6 receptor antagonist, effective in treating other autoimmune conditions and under investigation for IgG4-RD. 3. Belimumab: A monoclonal antibody targeting BLyS, used in systemic lupus erythematosus and being explored for IgG4-RD. 4. Abatacept: A CTLA-4-Ig fusion protein that modulates T-cell activation, showing promise in autoimmune diseases and being studied for IgG4-RD.

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Monoclonal Antibodies

Elotuzumab for IgG4-Related Disease

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

Summary

This trial tests if adding elotuzumab to the standard treatment of prednisone helps adults with active IgG4-RD, a disease that causes inflammation and damage in multiple organs. The study aims to see if this combination is safe and more effective.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

68%

DIARRHOEA

62%

MUSCLE SPASMS

51%

CONSTIPATION

49%

FATIGUE

46%

NAUSEA

46%

PYREXIA

41%

UPPER RESPIRATORY TRACT INFECTION

41%

INSOMNIA

38%

BACK PAIN

35%

ANAEMIA

35%

COUGH

35%

PAIN IN EXTREMITY

32%

ASTHENIA

32%

HYPERGLYCAEMIA

27%

THROMBOCYTOPENIA

27%

BRONCHITIS

27%

DYSPNOEA

27%

NIGHT SWEATS

24%

NEUTROPENIA

24%

OEDEMA PERIPHERAL

24%

PNEUMONIA

24%

RASH

24%

NASOPHARYNGITIS

22%

LYMPHOPENIA

22%

RHINITIS

22%

DECREASED APPETITE

22%

ARTHRALGIA

22%

BONE PAIN

19%

ABDOMINAL PAIN

19%

PERIPHERAL SWELLING

19%

HYPOKALAEMIA

19%

DIZZINESS

19%

NEUROPATHY PERIPHERAL

19%

HEADACHE

16%

LEUKOPENIA

16%

CATARACT

16%

VOMITING

16%

EPISTAXIS

16%

DYSGEUSIA

14%

VISION BLURRED

14%

PAIN

14%

ORAL CANDIDIASIS

14%

URINARY TRACT INFECTION

14%

HYPOPHOSPHATAEMIA

14%

PERIPHERAL SENSORY NEUROPATHY

14%

TREMOR

14%

DYSPNOEA EXERTIONAL

14%

NASAL CONGESTION

14%

RHINORRHOEA

14%

HYPERHIDROSIS

11%

HYPOTENSION

11%

ABDOMINAL PAIN UPPER

11%

GASTROOESOPHAGEAL REFLUX DISEASE

11%

CELLULITIS

11%

CONTUSION

11%

FALL

11%

ALANINE AMINOTRANSFERASE INCREASED

11%

ASPARTATE AMINOTRANSFERASE INCREASED

11%

BLOOD BICARBONATE DECREASED

11%

BLOOD CREATININE INCREASED

11%

WEIGHT DECREASED

11%

MUSCULOSKELETAL PAIN

11%

OROPHARYNGEAL PAIN

11%

ERYTHEMA

ATRIAL FIBRILLATION

DEPRESSION

FEBRILE NEUTROPENIA

VERTIGO

PANCYTOPENIA

HYPOACUSIS

EYE IRRITATION

CHEST PAIN

GASTROENTERITIS

INFLUENZA

LUNG INFECTION

WEIGHT INCREASED

HYPERCALCAEMIA

HYPOCALCAEMIA

VITAMIN D DEFICIENCY

MUSCULOSKELETAL CHEST PAIN

HYPOAESTHESIA

PARAESTHESIA

CONFUSIONAL STATE

BENIGN PROSTATIC HYPERPLASIA

DYSPHONIA

HICCUPS

ECCHYMOSIS

NECK PAIN

SINUSITIS

HYPOALBUMINAEMIA

OCULAR HYPERAEMIA

CHEST DISCOMFORT

SEPSIS

RENAL FAILURE

LYMPHADENOPATHY

PALPITATIONS

VITREOUS FLOATERS

ABDOMINAL DISTENSION

DRY MOUTH

CHILLS

GAIT DISTURBANCE

NON-CARDIAC CHEST PAIN

CONJUNCTIVITIS

LOCALISED INFECTION

PHARYNGITIS

VIRAL UPPER RESPIRATORY TRACT INFECTION

SKIN ABRASION

WHITE BLOOD CELL COUNT DECREASED

DEHYDRATION

DIABETES MELLITUS

GOUT

HYPOMAGNESAEMIA

HYPONATRAEMIA

OSTEONECROSIS OF JAW

BASAL CELL CARCINOMA

AMNESIA

MOOD SWINGS

DYSURIA

HAEMATURIA

POLLAKIURIA

LUNG DISORDER

PRODUCTIVE COUGH

PULMONARY EMBOLISM

SINUS CONGESTION

BLISTER

PRURITUS

RASH GENERALISED

SKIN DISCOLOURATION

DEEP VEIN THROMBOSIS

FLUSHING

HOT FLUSH

HYPERTENSION

BLOOD UREA INCREASED

MEMORY IMPAIRMENT

DRY EYE

DYSPEPSIA

ARTHROPOD BITE

SCAB

MUSCULAR WEAKNESS

PHLEBITIS

DRUG HYPERSENSITIVITY

ANGINA PECTORIS

VARICES OESOPHAGEAL

MULTIPLE ORGAN DYSFUNCTION SYNDROME

CHOLECYSTITIS

MENINGITIS

PNEUMONIA KLEBSIELLA

PYELONEPHRITIS

VISCERAL LEISHMANIASIS

ELECTROLYTE IMBALANCE

LOBULAR BREAST CARCINOMA IN SITU

BLADDER TRANSITIONAL CELL CARCINOMA

PROSTATE CANCER

MYELODYSPLASTIC SYNDROME

TRANSIENT GLOBAL AMNESIA

TRANSIENT ISCHAEMIC ATTACK

ACUTE RESPIRATORY FAILURE

PROSTATITIS

PNEUMONITIS

GASTROINTESTINAL HAEMORRHAGE

HAEMORRHOIDS

IRRITABILITY

OEDEMA

ORAL HERPES

ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED

BLOOD ALKALINE PHOSPHATASE INCREASED

BLOOD LACTATE DEHYDROGENASE INCREASED

CARDIAC MURMUR

NEUTROPHIL COUNT INCREASED

PROTHROMBIN TIME PROLONGED

HYPERKALAEMIA

MUSCULOSKELETAL DISCOMFORT

MUSCULOSKELETAL STIFFNESS

MYALGIA

BALANCE DISORDER

NEURALGIA

SINUS HEADACHE

SOMNOLENCE

SYNCOPE

ANXIETY

DEPRESSED MOOD

PARANASAL SINUS HYPERSECRETION

THROAT IRRITATION

UPPER-AIRWAY COUGH SYNDROME

SKIN LESION

INTERNATIONAL NORMALISED RATIO INCREASED

DRY SKIN

SQUAMOUS CELL CARCINOMA OF SKIN

VISUAL ACUITY REDUCED

FLATULENCE

STOMATITIS

PAIN IN JAW

RASH MACULO-PAPULAR

100%

80%

60%

40%

20%

Study treatment Arm

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

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)

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

diphenhydramine

2011

Completed Phase 4

~420

elotuzumab

2008

Completed Phase 3

~720

acetaminophen

2008

Completed Phase 4

~3130

famotidine

2019

Completed Phase 4

~4239010

prednisone

1999

Completed Phase 3

~10920

methylprednisolone

2004

Completed Phase 4

~1070

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Elotuzumab is a monoclonal antibody that targets SLAMF7, a protein found on the surface of immune cells, to modulate the immune response. By binding to SLAMF7, elotuzumab enhances the activity of natural killer (NK) cells and promotes the destruction of abnormal cells. This mechanism is particularly relevant for patients with IgG4-Related Disease (IgG4-RD) as it helps to regulate the immune system, potentially reducing inflammation and tissue damage caused by the disease. Monoclonal antibodies like elotuzumab are crucial in managing IgG4-RD because they offer targeted therapy, which can be more effective and have fewer side effects compared to broader immunosuppressive treatments.