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A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio

ConditionGeographic Atrophy Secondary to Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorApellis Pharmaceuticals, Inc.

About this trial

A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with better normal luminance visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the study eye.

Aged ≥60 years

Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes, as determined by the investigator and confirmed by the reading center

NL-BCVA of 50 letters or better using early treatment diabetic retinopathy study (ETDRS) charts (approximately 20/100 Snellen equivalent)

Disqualifiers

Uncontrolled, clinically relevant history of any gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cancer

History or presence of hepatic cirrhosis or other liver disease that may increase the risk of drug-induced liver injury

History or presence of systemic autoimmune disorders, with the exception of well controlled Hashimoto's thyroiditis

History of allergy, hypersensitivity, or serious adverse reaction to siRNA therapy or related compounds, or allergy to any of the components of the study drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • APL-3007, pegcetacoplan (APL-2)

    Drug

    Complement C3 inhibitor

  • APL-3007, pegcetacoplan (APL-2)

    Drug

    Complement C3 Inhibitor

  • Placebo, Syfovre

    Other intervention

    Complement C3 Inhibitor

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Group 1 (APL-3007 Dose/Frequency 1 )Experimental treatment 1 intervention
Group B: Group 2 (APL-3007 Dose/Frequency 2)Experimental treatment 1 intervention
Group C: Group 3 (placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline (CFB) in the area of artificial intelligence (AI)-based SD-OCT assessment of RPE lesion in the study eye

Time frame
At month 12

Secondary outcomes

1

CFB in the area of AI-based OCT assessment of photoreceptor degeneration in the study eye

Time frame
At month 12
2

Safety & tolerability based on adverse event (AE) reporting

Time frame
At month 12
3

Safety as assessed by Best Corrected Visual Acuity (BCVA)

Continuous monitoring of a subject' BCVA as assessed by EDTRS chart

Time frame
At Month 12
4

Change from baseline in Serum C3 level

Continuous monitoring of a subject's Serum C3 level

Time frame
At Month 12

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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