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Evaluating IMVT-1402 for difficult-to-treat rheumatoid arthritis

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis

Phase 2 Interventional Immunovant Sciences GmbH · NCT06754462

This study is testing a new treatment called IMVT-1402 to see if it can help adults with tough-to-treat rheumatoid arthritis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Drugs / interventionsrituximab
Locations37 sites (Anniston, Alabama and 36 other locations)
Trial IDNCT06754462 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial assesses the efficacy and safety of IMVT-1402 in adults with active, difficult-to-treat rheumatoid arthritis who are positive for anti-citrullinated protein autoantibodies. Participants will first receive open-label treatment with IMVT-1402 for 16 weeks, followed by a randomized withdrawal phase where they will receive either IMVT-1402 or a placebo for 12 weeks. The primary goal is to measure the proportion of participants achieving an American College of Rheumatology 20% response at the end of the withdrawal phase. The study also aims to evaluate the safety and tolerability of the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with rheumatoid arthritis who have not responded adequately to at least two classes of biologic or targeted synthetic DMARDs.

Not a fit: Patients with a history of malignancy within the last five years or those who have received rituximab without sufficient efficacy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat rheumatoid arthritis.

How similar studies have performed: Other studies have shown promise with similar approaches targeting rheumatoid arthritis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

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.

Where this trial is running

Anniston, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rheumatoid ArthritisAnticitrullinated protein autoantibodiesDifficult-to-treatAnti-FcRnIMVT-1402 Autoimmune Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.