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

Phase 2

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT06754462
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

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). The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response.

Detailed Description

The study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety.

The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
• C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.
• DAS28-CRP > 4.1 at the Screening Visit.
• Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
• Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs.

Additional inclusion criteria are defined in the protocol.

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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 non-immunosuppressive Fc-based therapeutic protein (e.g., 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMVT-1402/Placebo	IMVT-1402	Period 1: Open-label IMVT-1402 600 mg SC QW Period 2: Randomized to placebo SC QW Period 3: IMVT-1402 600 mg SC QW
IMVT-1402/Placebo	Placebo	Period 1: Open-label IMVT-1402 600 mg SC QW Period 2: Randomized to placebo SC QW Period 3: IMVT-1402 600 mg SC QW
IMVT-1402 600 mg/ IMVT-1402 300 mg	IMVT-1402	Period 1: Open-label IMVT-1402 600 mg SC QW Period 2: Randomized to IMVT-1402 300mg SC QW Period 3: IMVT-1402 300 mg SC QW
IMVT-1402 600 mg/ IMVT-1402 600 mg	IMVT-1402	Period 1: Open-label IMVT-1402 600 mg SC QW Period 2: Randomized to IMVT-1402 600mg SC QW Period 3: IMVT-1402 600 mg SC QW

Primary Outcome Measures

Name	Time	Method
For participants in Period 2: proportion of participants who maintain ACR20 response at Week 28 compared to baseline from Period 1	From baseline to Week 28

Secondary Outcome Measures

Name	Time	Method
For participants in Period 2, change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28	Week 16 to Week 28
For participants in Period 2, change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28	Week 16 to Week 28