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

NCT06087406 | Terminated Phase 1 FDA Drug

• 1 other identifier: IGM-2323-102
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 18

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

Conditions

Rheumatoid Arthritis; Arthritis, Rheumatoid; Arthritis

Keywords

Arthritis; Moderate to severe arthritis; active rheumatoid arthritis; bDMARD; tsDMARD; refractory

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Imvotamab (Dose Escalation)

EXPERIMENTAL

Imvotatmab administered intravenously

Drug: Imvotamab

PBO IV

PLACEBO COMPARATOR

Placebo administered intravenously

Drug: Placebo

Interventions

Imvotamab DRUG

Administered intravenously

Imvotamab (Dose Escalation)

Placebo DRUG

0.9% sodium chloride administered intravenously

PBO IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (18)

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, 860001, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, 85306, United States

Location

Triwest Research Associates

San Diego, California, 92108, United States

Location

East Bay Rheumatology Medical Group

San Leandro, California, 94578, United States

Location

University of Colorado Hopsital - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Omega Research MetroWest

Orlando, Florida, 32855, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

Accelacare - Salisbury

Salisbury, North Carolina, 28144, United States

Location

Southwest Rheumatology Research

Mesquite, Texas, 75150, United States

Location

Centrum Reumatologii i Rehabilitacji NOVA REUMA

Bialystok, Podlaskie Voivodeship, Poland

Location

Nova Reuma Domyslawska i Rusilowicz Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, Poland

Location

Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie

Nadarzyn, Poland

Location

Med Polonia Sp. z o. o. - Obornicka

Poznan, Poland

Location

Medyczne Centrum Hetmanska

Poznan, Poland

Location

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

Poznan, Poland

Location

Reumedika s.c. Wiesława i Łukasz Porawscy

Poznan, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric Humke, MD

  IGM Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: March 15, 2023
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-01

Locations

US (10); PL (8)