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A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

NCT06754462

Active Not RecruitingPhase 2

Sponsor: Immunovant Sciences GmbH

Conditions: Rheumatoid Arthritis

Interventions: IMVT-1402, Placebo

Countries: United States, Argentina, Bulgaria, Czechia, Georgia, Germany, Hungary, Poland

This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male and Female participants of age \>18 years will be enrolled.
* Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
* Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen joint count (SJC) at both Screening and Baseline visits.
* C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.
* Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
* Inadequate response to at least 2 classes of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

* Have received rituximab and experienced insufficient efficacy or loss of efficacy
* History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA.
* Active malignancy or history of malignancy within 5 years prior to Screening Visit.
* Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
* Used any nonimmunosuppressive fragment crystallizable (Fc)-based therapeutic protein (e.g., monoclonal antibody \[mAb\] or Fc-fusion protein) within 4 weeks prior to or at Screening Visit.
* Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.

Other, more specific exclusion criteria are defined in the protocol.

Locations (83)

Mesa, Arizona, United States
Sun City, Arizona, United States
Covina, California, United States
San Leandro, California, United States
Temecula, California, United States
Tujunga, California, United States
Whittier, California, United States
Denver, Colorado, United States
Jupiter, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Gainesville, Georgia, United States
Chicago, Illinois, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Rockville, Maryland, United States
Worcester, Massachusetts, United States
Saint Clair Shores, Michigan, United States
Kansas City, Missouri, United States
Summit, New Jersey, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Duncansville, Pennsylvania, United States
Jackson, Tennessee, United States
Memphis, Tennessee, United States
Murfreesboro, Tennessee, United States
Allen, Texas, United States
Colleyville, Texas, United States
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