APL2 in FSGS: a two-stage study to see if twice-weekly injections help adults and teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a sequential phase 2/3 interventional study in adults and, where approved, adolescents with focal segmental glomerulosclerosis (FSGS). The phase 2 portion is open-label and single-arm to evaluate the safety and potential efficacy of APL2 in adults. After completing phase 2, participants will be randomized in phase 3 to receive APL2 or placebo in a double-blind, multicenter comparison. Eligible participants must have diagnosed FSGS, specific proteinuria and kidney function criteria, and stable concurrent treatment for at least 12 weeks prior to randomization. Exclusion criteria include prior exposure to APL2 and evidence of recent kidney improvement.

Why it matters

Who can join: the full rules

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

Where it's running

• Investigator Site 1
  Chicago, Illinois, United States Recruiting
• Investigator Site 2
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Apellis Clinical Trial Information Line
• Email: clinicaltrials@apellis.com
• Phone: 833-284-6361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.