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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

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.
Key

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06087406
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IGM Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rebecca Kunder
Principal Investigator Affiliation IGM Biosciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Arthritis, Rheumatoid, Arthritis
Additional Details

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 24 participants will be sequentially assigned to different dose escalation cohorts.

Arms & Interventions

Arms

Experimental: Imvotamab (Dose Escalation)

Imvotatmab administered intravenously

Placebo Comparator: PBO IV QW x 4 doses

Placebo administered intravenously

Interventions

Drug: - Imvotamab

Administered intravenously

Drug: - Placebo

0.9% sodium chloride administered intravenously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Anniston Medical Clinic, Anniston, Alabama

Status

Recruiting

Address

Anniston Medical Clinic

Anniston, Alabama, 36207

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Flagstaff, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, 860001

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, 85306

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Triwest Research Associates, San Diego, California

Status

Recruiting

Address

Triwest Research Associates

San Diego, California, 92108

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

East Bay Rheumatology Medical Group, San Leandro, California

Status

Recruiting

Address

East Bay Rheumatology Medical Group

San Leandro, California, 94578

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

San Leandro, California

Status

Recruiting

Address

Precision Comprehensive Clinical Research Solutions

San Leandro, California, 94578

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Hopsital - Anschutz Medical Campus

Aurora, Colorado, 80045

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Aventura, Florida

Status

Recruiting

Address

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, 33180

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Advanced Pharma - Miami, Miami, Florida

Status

Recruiting

Address

Advanced Pharma - Miami

Miami, Florida, 33147

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Omega Research MetroWest, Orlando, Florida

Status

Recruiting

Address

Omega Research MetroWest

Orlando, Florida, 32855

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Plantation, Florida

Status

Recruiting

Address

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Accelacare - Salisbury, Salisbury, North Carolina

Status

Recruiting

Address

Accelacare - Salisbury

Salisbury, North Carolina, 28144

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Care and Cure Clinic, Houston, Texas

Status

Recruiting

Address

Care and Cure Clinic

Houston, Texas, 77090

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Southwest Rheumatology Research, Mesquite, Texas

Status

Recruiting

Address

Southwest Rheumatology Research

Mesquite, Texas, 75150

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

International Sites

Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Centrum Reumatologii i Rehabilitacji NOVA REUMA

Bialystok, Podlaskie,

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Bydgoszcz, Poland

Status

Recruiting

Address

Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz

Bydgoszcz, ,

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Medyczne Centrum Hetmanska, Poznań, Poland

Status

Recruiting

Address

Medyczne Centrum Hetmanska

Poznań, ,

Site Contact

Clinical Trials

[email protected]

(877) 544-6728

Reumedika, Poznań, Poland

Status

Recruiting

Address

Reumedika

Poznań, ,

Site Contact

Clinical Trials

[email protected]

(877) 544-6728