Recruiting
Phase 2
Phase 3

APL2

Sponsor:

Apellis Pharmaceuticals, Inc.

Code:

NCT07213960

Conditions

FSGS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APL2

Placebo

Study Details

Brief summary:

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.

Conditions

FSGS

Study ID

NCT07213960

Start date

Dec, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age

  • Phase 2: adults aged ≥18 years
  • Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form
  • Weight ≥30 kg and ≤100 kg at screening
  • FSGS diagnosis

  • Phase 2: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy
  • Phase 3: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy or by recognized podocyte genetic mutation
  • At least 1.5 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g/g in at least 2 FMU samples collected during screening
  • Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2
  • Stable regimen for FSGS treatment for at least 12 weeks prior to randomization, with no planned or anticipated adjustments or dose changes to the stable treatment regimen

Exclusion Criteria:

  • Previous exposure to APL2
  • Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
  • FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
  • Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
  • History of kidney transplant
  • Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses
  • Hypersensitivity to APL2 or to any of the excipients
  • Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results
  • Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

APL2

Complement (C3) Inhibitor

Placebo

Sterile solution of equal volume to active arm

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 ]
  • Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR) [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Central contacts

Apellis Clinical Trial Information Line

833-284-6361clinicaltrials@apellis.com

Locations

Investigator Site 1

Recruiting

Chicago, Illinois, United States, 60643

Investigator Site 2

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Apellis Pharmaceuticals, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Glomerulosclerosis
  • Focal Segmental
  • Child
  • Adult
  • Peptides
  • Cyclic
  • Complement Inactivator Proteins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Apellis Pharmaceuticals, Inc. on 2026-09-02.