A phase 2b study to assess IMVT-1402 in Adult Participants with Primary Sjogren’s Disease
Research type
Research Study
Full title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity
IRAS ID
1012101
Contact name
Sarah York
Contact email
Sponsor organisation
Immunovant Sciences GmbH
Clinicaltrials.gov Identifier
Research summary
With Sjogrenʼs disease, the body makes harmful antibodies, which affect the glands in the body that produce moisture. Sjogren’s disease causes dry eyes, which may make eyes burn, itch, or feel gritty. Sjogren’s disease can also cause dry mouth, which can make it difficult to talk or swallow. Sjogren’s disease can also cause dry skin, dry vagina, joint pain, and tiredness. All of which can severely affect quality of life. These harmful antibodies can also affect other organs such as nerves which can sometimes lead to paralysis and constant pain.
This study will test a new treatment for Sjogrenʼs disease called IMVT-1402.
The study has 4 periods:
- A screening period (up to 35 days) - will check if potential participants can enter the study.
- Treatment Period 1 (24 weeks) - participants will take IMVT-1402 dose 1, IMVT-1402 dose 2, or placebo for 24 weeks.
- Treatment Period 2 (24 weeks) - participants taking IMVT-1402 at the end of Period 1 will continue to take the same dose of IMVT-1402 for another 24 weeks.
- Follow-up Period (4 weeks) - After a participantʼs last dose of study treatment, the participant will have a safety follow-up visit to check on their health.REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0707
Date of REC Opinion
13 Nov 2025
REC opinion
Further Information Favourable Opinion