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

NCT ID: NCT06087406

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-02-10

Brief 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.

Conditions

Rheumatoid Arthritis; Arthritis, Rheumatoid; Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Imvotamab (Dose Escalation)

Imvotatmab administered intravenously

Group Type: EXPERIMENTAL

Imvotamab

Intervention Type: DRUG

Administered intravenously

PBO IV

Placebo administered intravenously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% sodium chloride administered intravenously

Interventions

Imvotamab

Administered intravenously

Intervention Type: DRUG

Placebo

0.9% sodium chloride administered intravenously

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGM Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Humke, MD

Role: STUDY_DIRECTOR

IGM Biosciences

Locations

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

Centrum Reumatologii i Rehabilitacji NOVA REUMA

Bialystok, Podlaskie Voivodeship, Poland

Nova Reuma Domyslawska i Rusilowicz Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, , Poland

Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz

Bydgoszcz, , Poland

Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie

Nadarzyn, , Poland

Med Polonia Sp. z o. o. - Obornicka

Poznan, , Poland

Medyczne Centrum Hetmanska

Poznan, , Poland

Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj

Poznan, , Poland

Reumedika s.c. Wiesława i Łukasz Porawscy

Poznan, , Poland

Countries

United States; Poland

Other Identifiers

IGM-2323-102

Identifier Type: -

Identifier Source: org_study_id