A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT07213960
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • FSGS

Eligibility Criteria

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

Interventions

  • APL2 — DRUG
    Complement (C3) Inhibitor
  • Placebo — OTHER
    Sterile solution of equal volume to active arm

Study Details

This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

Key Dates

Start date
Dec 31, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Phase 2 - APL2
    Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly
  • Experimental: Phase 3 - APL2
    Adults: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly Adolescents: ≥50 Kg: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly 35 to \<50kg: First sub-cutaneous infusion of 648mg (12 mL) followed by 810mg (15 mL) every infusion thereafter (i.e. twice weekly) 30 to \<35kg: First \& Second sub-cutaneous infusion of 540mg (10mL) followed by 648mg (12 mL) every infusion thereafter (twice weekly)
  • Placebo Comparator: Phase 3 - Placebo
    Subcutaneous infusions of a sterile solution, twice-weekly, and equivalent in volume to the active arm based on participant's age and weight

Primary Outcome Measure

Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR) [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Investigator Site 1ChicagoIllinois60643-
Investigator Site 2New YorkNew York10032-

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