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Monoclonal Antibodies

IMVT-1402 for Rheumatoid Arthritis

Anniston, AL
Phase 2
Recruiting
Research Sponsored by Immunovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to test the effectiveness and safety of IMVT-1402 in adults with rheumatoid arthritis who have not responded well to other treatments. The study will compare IMVT-1402

See full description
Who is the study for?
This trial is for adults with active, hard-to-treat rheumatoid arthritis who have not responded well to at least two types of advanced RA medications. Participants must meet specific criteria including a definite RA diagnosis, certain levels of joint tenderness and swelling, elevated C-reactive protein, and positive ACPA.Check my eligibility
What is being tested?
The study tests IMVT-1402 against a placebo in people with difficult rheumatoid arthritis. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), and aims to see if IMVT-1402 can improve symptoms better than an inactive substance.See study design
What are the potential side effects?
While the side effects are not detailed here, typical ones for RA treatments may include injection site reactions, increased risk of infections, headaches, nausea, and potential liver issues. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not improved after trying two different types of advanced arthritis treatments.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: IMVT-1402 600 mg/ IMVT-1402 600 mgExperimental Treatment1 Intervention
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
Group II: IMVT-1402 600 mg/ IMVT-1402 300 mgExperimental Treatment1 Intervention
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
Group III: IMVT-1402/PlaceboPlacebo Group2 Interventions
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

Find a Location

Closest Location:Site Number - 1021· Saint Clair Shores, MI· 176 miles

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor
11 Previous Clinical Trials
1,276 Total Patients Enrolled
~80 spots leftby Sep 2027
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