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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087406
• Other study ID #: IGM-2323-102
• Status: Recruiting
• Phase: Phase 1
• Start date: September 13, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: IGM Biosciences, Inc.
• Contact: Clinical Trials
• Phone: (877) 544-6728
• Email: IGM-2323-102[@]igmbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Imvotamab
Administered intravenously
• Placebo
0.9% sodium chloride administered intravenously

Locations

Country	Name	City	State
Poland	Centrum Reumatologii i Rehabilitacji NOVA REUMA	Bialystok	Podlaskie
Poland	Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz	Bydgoszcz
Poland	Medyczne Centrum Hetmanska	Poznan
Poland	Reumedika	Poznan
United States	Anniston Medical Clinic	Anniston	Alabama
United States	University of Colorado Hopsital - Anschutz Medical Campus	Aurora	Colorado
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Arizona Arthritis & Rheumatology Research, PLLC	Flagstaff	Arizona
United States	Arizona Arthritis & Rheumatology Research, PLLC	Glendale	Arizona
United States	Care and Cure Clinic	Houston	Texas
United States	Southwest Rheumatology Research	Mesquite	Texas
United States	Advanced Pharma - Miami	Miami	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	Triwest Research Associates	San Diego	California
United States	East Bay Rheumatology Medical Group	San Leandro	California
United States	Precision Comprehensive Clinical Research Solutions	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
IGM Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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