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Tests treatment safety and results for Primary Sjögren's Syndrome
Official title Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
ClinicalTrials.gov ID: NCT06979531
What this study is testing
What is IMVT-1402?
IMVT-1402 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for primary sjögren's syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS...
- 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...
You likely can't join if
- Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic...
- Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined...
The study team makes the final eligibility decision.
Where it's taking place
- Covina, California, United States
- El Cajon, California, United States
- Menifee, California, United States
- Thousand Oaks, California, United States
- Upland, California, United States
- Fort Collins, Colorado, United States
- Hollywood, Florida, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Orland Park, Illinois, United States
- Lake Charles, Louisiana, United States
- New Orleans, Louisiana, United States
- Canton, New York, United States
- Mineola, New York, United States
- Philadelphia, Pennsylvania, United States
- Jackson, Tennessee, United States
- Memphis, Tennessee, United States
+ 79 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Covina, California, United States; El Cajon, California, United States; Menifee, California, United States; Thousand Oaks, California, United States; Upland, California, United States; Fort Collins, Colorado, United States and 93 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.