To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C). The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
344
Clinical Research of West Florida Inc
Tampa, Florida, United States
RECRUITINGPart A and B: Change from baseline in ESSDAI score
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD. Score range is 0-123. Higher scores on the ESSDAI scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Time frame: Baseline, Week 24
Part C: Change from baseline in ESSPRI
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Time frame: Baseline, Week 24
Part A and B: Change from baseline in ESSPRI
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Time frame: Baseline, Week 24
Part A, B and C: Change from baseline in SSSD
Sjögren's Syndrome Symptom Diary (SSSD) includes six items specific to SjD (eye dryness, mouth dryness skin dryness, tiredness, muscle and/or joint pain, and genital dryness). The total score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Time frame: Baseline, Week 24
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Chicago Clinical Research Inst
Chicago, Illinois, United States
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Willowbrook, Illinois, United States
RECRUITINGRAO Research LLC
Oklahoma City, Oklahoma, United States
RECRUITINGAltoona Center for Clin Res
Duncansville, Pennsylvania, United States
RECRUITINGStryde Research-Allen Arthritis
Allen, Texas, United States
RECRUITINGNovel Research LLC
Bellaire, Texas, United States
RECRUITINGArthritis Care of Texas
Corpus Christi, Texas, United States
RECRUITINGNovartis Investigative Site
Southport, Queensland, Australia
RECRUITINGNovartis Investigative Site
Nedlands, Western Australia, Australia
RECRUITING...and 10 more locations
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of multiple doses of DDY391.
Time frame: Baseline up to Week 52