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

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

Study Overview

• Status: Terminated
• Conditions: Arthritis; Arthritis, Rheumatoid; Rheumatoid Arthritis
• Intervention / Treatment: Drug: Imvotamab; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland
    • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
  • Bydgoszcz, Poland
    • Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz
  • Nadarzyn, Poland
    • Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
  • Poznań, Poland
    • Medyczne Centrum Hetmańska
  • Poznań, Poland
    • Med Polonia Sp. z o. o. - Obornicka
  • Poznań, Poland
    • Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
  • Poznań, Poland
    • Reumedika s.c. Wiesława i Łukasz Porawscy
  • Podlaskie
    • Bialystok, Podlaskie, Poland
      • Centrum Reumatologii i Rehabilitacji NOVA REUMA
• United States
  • Arizona
    • Flagstaff, Arizona, United States, 860001
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • San Diego, California, United States, 92108
      • TriWest Research Associates
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hopsital - Anschutz Medical Campus
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheumatic Disease Specialties
    • Orlando, Florida, United States, 32855
      • Omega Research MetroWest
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Accelacare - Salisbury
  • Texas
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imvotamab (Dose Escalation); Imvotatmab administered intravenously	Drug: Imvotamab; Administered intravenously
Placebo Comparator: PBO IV; Placebo administered intravenously	Drug: Placebo; 0.9% sodium chloride administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis	Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events (SIEs) and opportunistic infections (OIs)	Up to Week 52

Collaborators and Investigators

• Sponsor: IGM Biosciences, Inc.
• Investigators: Study Director: Eric Humke, MD, IGM Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Arthritis; refractory; bDMARD; active rheumatoid arthritis; Moderate to severe arthritis; tsDMARD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IGM-2323-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No