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

ConditionFSGS
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorApellis Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • APL2

    Drug

    Complement (C3) Inhibitor

  • Placebo

    Other intervention

    Sterile solution of equal volume to active arm

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Phase 2 - APL2Experimental treatment 1 intervention
Group B: Phase 3 - APL2Experimental treatment 1 intervention
Group C: Phase 3 - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR)

Change from Baseline in Log-Transformed uPCR will be based on triplicate first morning urine (FMU)

Time frame
Baseline to Week 12
2

Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR)

Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)

Time frame
Baseline to Week 52

Secondary outcomes

1

Phase 2: Evaluate the efficacy of APL2 in terms of change from baseline in log-transformed urine albumin to creatinine ratio (uACR)

Change From Baseline in Log-Transformed uACR will be based on first morning urine (FMU)

Time frame
Baseline to Week 12
2

Phase 3: Change from Baseline in log-transformed urine protein to creatinine ratio (uPCR)

Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)

Time frame
Baseline to Week 104
3

Phase 3: Proportion of participants achieving Complete Remission

Complete Remission is defined as participants who have achieved uPCR \<0.3 g/g

Time frame
Week 104
4

Phase 3: Slope of estimated Glomerular Filtration Rate (eGFR)

The annualized eGFR slope

Time frame
Baseline to Week 104

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apellis Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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