Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy

Sponsor
Sitala Bio LTD
Study ID
NCT07606352
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STL303 — DRUG
    STL303 arm participants will receive a specific dose of STL303
  • STL303 — DRUG
    STL303 arm participants will receive a specific dose of STL303
  • Placebo capsule — DRUG
    Placebo arm participants will receive placebo capsules

Study Details

This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of STL303 capsules in IgAN patients. About 15 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of STL303 or placebo capsules orally according to protocol.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: STL303 dose level 1
    Participants will receive STL303 dose level 1
  • Experimental: STL303 Dose Level 2
    Participants will receive STL303 dose level 2
  • Placebo Comparator: Placebo
    Participants will receive placebo

Primary Outcome Measure

Treatment emergent adverse events (TEAEs), adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Adverse events will be closely monitored, and participants will report to the clinic on Days 7, 14, 30, 45, 60, 90, 135 and at end of treatment on Day 180. On Day 210 an End of study safety follow up will also be conducted. ]

Central Contacts

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