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A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

A Phase 1b, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Failed Prior Therapies

NCT06087406•IGM Biosciences, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug

Detailed Description

This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 40 participants will be sequentially assigned to different dose escalation cohorts.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at the time of signing ICF
•Documented diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 1 year prior to screening
•Have had treatment with bDMARDs and/or tsDMARD and were refractory by 1 of 2 reasons:
•* Lack of benefit to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD, after at least 12 weeks of treatment, in the opinion of the investigator. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
•* Intolerance to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD.
•Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)
•Central lab results for hsCRP ≥ 0.8 mg/dL
•Anti-citrullinated protein antibodies (ACPA) positive and/or rheumatoid factor (RF) positive
•If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 10 mg/day of prednisone for at least 2 weeks prior to first study treatment

Exclusion Criteria

•History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA
•Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
•Receipt of any of the following excluded RA therapies:
•* Any cell depleting therapy, anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab, less than 6 months prior to first administration of study treatment.
•* Have received prior tsDMARds including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agent less than 3 months or 5 half-lives, whichever is longer, prior to first administration of study treatment
•* Have received prior immunomodulatory bDMARDs for RA including, but not limited to adalimumab, golimumab, ustekinumab, secukinumab, tocilizumab, abatacept, or other inhibitors of TNF, IL-6, IL-23, or IL-17 less than 3 months or 5 half-lives, whichever is longer, prior to first administration of the study treatment
•Requiring therapy with prednisone \> 10 mg/day (or equivalent dose) within 2 weeks prior to first study treatment

Locations (18)

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, United States

Triwest Research Associates

San Diego, California, United States

East Bay Rheumatology Medical Group

San Leandro, California, United States

University of Colorado Hopsital - Anschutz Medical Campus

Aurora, Colorado, United States

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

Omega Research MetroWest

Orlando, Florida, United States

Integral Rheumatology & Immunology Specialists

Plantation, Florida, United States

Accelacare - Salisbury

Salisbury, North Carolina, United States

Southwest Rheumatology Research

Mesquite, Texas, United States

Key Dates

Start Date

March 15, 2023

Primary Completion Date

February 10, 2025

Completion Date

February 10, 2025

Last Updated

February 18, 2025

Enrollment

ACTUAL participants

Conditions

Rheumatoid ArthritisArthritis, RheumatoidArthritis

Interventions

Imvotamab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of Picankibart in Patients With Active Psoriatic Arthritis

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Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis