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RecruitingPhase 2/Phase 3

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

Apellis Pharmaceuticals, Inc. · NCT07213960

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
270
US sites recruiting
2
Study start
December 2026
Record last updated
September 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: APL2; Placebo

Conditions: FSGS

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Apellis Clinical Trial Information Line · 833-284-6361 · clinicaltrials@apellis.com
A Sequential Phase 2/3 Study of APL2 in Patients With Focal… (NCT07213960) | Bored Studies