Clinical trial NCT06087406: A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Arthritis, Rheumatoid
Arthritis
Keywords: Arthritis
Moderate to severe arthritis
active rheumatoid arthritis
bDMARD
tsDMARD
refractory
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis
timeFrame: Up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: San Diego
country: United States
facility: Triwest Research Associates
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Hopsital - Anschutz Medical Campus
state: Colorado
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Orlando
country: United States
facility: Omega Research MetroWest
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Salisbury
country: United States
facility: Accelacare - Salisbury
state: North Carolina
city: Mesquite
country: United States
facility: Southwest Rheumatology Research
state: Texas
city: Bialystok
country: Poland
facility: Centrum Reumatologii i Rehabilitacji NOVA REUMA
state: Podlaskie
city: Bialystok
country: Poland
facility: Nova Reuma Domyslawska i Rusilowicz Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty
city: Bydgoszcz
country: Poland
facility: Medicover Integrated Clinical Services (MCIS) Centrum Medyczne Bydgoszcz
city: Nadarzyn
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie
city: Poznań
country: Poland
facility: Med Polonia Sp. z o. o. - Obornicka
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmanska
city: Poznań
country: Poland
facility: Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
city: Poznań
country: Poland
facility: Reumedika s.c. Wiesława i Łukasz Porawscy
Study officials:
affiliation: IGM Biosciences
name: Eric Humke, MD
role: STUDY_DIRECTOR
References: