Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMVT-1402, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Sjögren's Syndrome. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Canada, Chile +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
Detailed description
The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24.
The total duration of study participation is expected to be up to 105 weeks for an individual participant.
Interventions
- Drug IMVT-1402
Administered once weekly by subcutaneous injection - Drug Placebo
Administered once weekly by subcutaneous injection
Primary outcome measures
- Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Time frame: Baseline and at Week 24]
Secondary outcome measures (7)
- Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Time frame: Week 24]
- Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Time frame: Baseline, Week 24]
- Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Time frame: Week 24]
- Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo [Time frame: Week 48]
- Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo [Time frame: Week 48]
- Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [Time frame: Baseline and at Week 24]
- Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo [Time frame: Baseline and at Week 24]
Eligibility criteria
Inclusion criteria
- Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
- Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
- Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
- Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.
Additional inclusion criteria are defined in the protocol.
Exclusion criteria
- Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
- Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
Additional exclusion criteria are defined in the protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 29 centers
- Site Number - 1027 — Covina
- Site Number - 1007 — El Cajon
- Site Number - 1016 — Menifee
- Site Number - 1029 — Thousand Oaks
- Site Number - 1026 — Upland
- Site Number - 1014 — Fort Collins
- Site Number - 1018 — Hollywood
- Site Number - 1021 — Jupiter
- … and 21 more centers
Poland · 16 centers
Center list to be confirmed — check the primary protocol.
Argentina · 9 centers
- Site number - 5005 — Azcuénaga
- Site Number - 5007 — Capital Federal
- Site Number - 5008 — San Isidro
- Site Number - 5004 — San Miguel de Tucumán
- Site Number - 5000 — Buenos Aires
- Site Number - 5002 — Buenos Aires
- Site Number - 5003 — Buenos Aires
- Site Number - 5001 — Buenos Aires
- … and 1 more center
Chile · 8 centers
- Site Number - 5700 — Santiago
- Site Number - 5702 — Santiago
- Site Number - 5703 — Santiago
- Site Number - 5701 — Santiago
- Site Number - 5704 — Santiago
- Site Number - 5706 — Viña del Mar
- Site Number - 5705 — Osorno
- Site Number - 5707 — Valdivia
Mexico · 8 centers
- Site Number - 2602 — Guadalajara
- … and 7 more centers
Germany · 7 centers
- Site Number - 6504 — Bad Doberan
- Site Number - 6506 — Cologne
- Site Number - 6500 — Hamburg
- Site Number - 6501 — Hanover
- Site Number - 6503 — Heidelberg
- Site number - 6502 — Munich
- Site Number - 6505 — Munich
Italy · 7 centers
- Site Number - 6000 — Catania
- Site Number - 6001 — Milan
- Site Number - 6006 — Naples
- Site Number - 6002 — Palermo
- Site Number - 6005 — Perugia
- Site Number - 6003 — Rome
- Site Number - 6007 — Salerno
Brazil · 6 centers
- Site Number - 5506 — Vitória
- Site Number - 5504 — Salvador
- Site Number - 5500 — Juiz de Fora
- Site Number - 5501 — Curitiba
- Site Number - 5503 — Porto Alegre
- Site Number - 5505 — Porto Alegre
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
Colombia · 5 centers
- Site Number - 5800 — Medellín
- Site Number - 5804 — Barranquilla
- Site Number - 5803 — Bogotá
- Site Number - 5802 — Chía
- Site Number - 5801 — Bucaramanga
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Hungary · 4 centers
- Site Number - 7550 — Budapest
- Site Number - 7552 — Hódmezővásárhely
- Site Number - 7551 — Kalocsa
- Site Number - 7553 — Székesfehérvár
Peru · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 3 centers
Center list to be confirmed — check the primary protocol.
Canada · 2 centers
- Site Number - 2001 — Sherbrooke
- Site Number - 2000 — Trois-Rivières
Greece · 2 centers
- Site Number - 3901 — Athens
- Site Number - 3900 — Athens
Identifiers
NCT: NCT06979531 · IMVT-1402-2801 · 2025-520831-18-00