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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
Time frame: Baseline and at Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
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
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 24
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 48
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Number - 1027
Covina, California, United States
RECRUITINGSite Number - 1007
El Cajon, California, United States
RECRUITINGSite Number - 1016
Menifee, California, United States
RECRUITINGSite Number - 1029
Thousand Oaks, California, United States
RECRUITINGSite Number - 1026
Upland, California, United States
RECRUITINGSite Number - 1014
Fort Collins, Colorado, United States
RECRUITINGSite Number - 1018
Hollywood, Florida, United States
RECRUITINGSite Number - 1021
Jupiter, Florida, United States
RECRUITINGSite Number - 1002
Miami, Florida, United States
RECRUITINGSite Number - 1004
Tamarac, Florida, United States
RECRUITING...and 111 more locations
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Time frame: Baseline and at Week 24
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Time frame: Baseline and at Week 24