Not yet recruiting NCT07727486
A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome
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: ICP-488 Tablets, ICP-488 Placebo.
- Who it may be relevant to
- Registry conditions: Primary Sjögren's Syndrome. Basic parameters: 18 years — 70 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
- China
- 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 Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)
Overview
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).
Interventions
- Drug ICP-488 Tablets
Specified dose on specified days - Drug ICP-488 Placebo
Specified dose on specified days
Primary outcome measures
- Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24 [Time frame: Baseline, Week 24]
Secondary outcome measures (10)
- Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period. [Time frame: Baseline, Week 24]
- Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period. [Time frame: Baseline, Week 24]
- Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period. [Time frame: Baseline, Week 24]
- Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period. [Time frame: Baseline, Week 24]
- Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period. [Time frame: Baseline, Week 24]
- Treatment-emergent adverse events. [Time frame: Through study completion, an average of 1 year]
- Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline. [Time frame: Through study completion, an average of 1 year]
- Maximum Concentration at Steady State(Cmax,ss) [Time frame: Through study completion, an average of 1 year]
- Steady-State Time to Maximum [Time frame: Through study completion, an average of 1 year]
- Area under the curve (AUC) [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Aged 18 to 70 years inclusive.
- The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
- The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
- At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
- Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
- Stable treatment regimen that can be continued until the end of study treatment (Week 48).
- Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception correctly during the study treatment period and for 1 month (28 days) after the last dose.
- Male participants with a WOCBP partner must agree to use protocol-specified contraceptive methods during the study treatment period and for 3 days after the last dose.
Exclusion criteria
- SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
- Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
- Presence of any other medical condition associated with SjS symptoms.
- Participants with a history of any clinically significant disease other than pSjS.
- Significant ECG abnormalities at screening requiring treatment.
- Participants with gastrointestinal diseases or gastrointestinal surgery present within 3 months prior to the screening visit that could affect the absorption of the study drug.
- Current or past history of bleeding disorders or diseases related to platelet dysfunction.
- Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.
- Participants with any uncontrolled clinically significant laboratory abnormality that, in the opinion of the investigator, could affect the interpretation of study data or the participant's participation in the study.
- Participants considered by the investigator to be unsuitable for participation in this study for any reason.
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
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 22 centers
- Peking — Beijing
- Chongqing Traditional Chinese Medicine Hospital — Chongqing
- "Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medica — Chongqing
- The First Affiliated Hospital of Xiamen University — Xiamen
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
- The First Affiliated Hospital of Guangxi Medical University — Nanning
- The Second Hospital of Hebei Medical University — Shijiazhuang
- … and 14 more centers
Identifiers
NCT: NCT07727486 · ICP-CL-01010