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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy Secondary to Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT07215390

Run by

Apellis Pharmaceuticals, Inc.

People needed

240

Starts

2025-06-23

Expected to finish

2027-11-01

Last updated by the study team

2026-06-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images in the study eye as determined by the investigator
• Prior treatment for GA in the study eye using Syfovre at 6-8 weeks interval for at least 6 months but no more than 24 months. Participants will be included if the participant has had at least 2 Syfovre injections in the last 6 months before screening.
• The GA lesion in at least 1 eye (designated as the study eye) must meet the following criteria as determined by the central reading center's OCT based RPE assessment of imaging at screening:
• Total GA area must be ≥2.5 and ≤17.5 mm2 (1-7 disk areas [DA])
• If GA is multifocal, at least 1 focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 7a
• The entire GA lesion must be completely visualized in the field of view of the OCT, with the GA RPE lesion border >500 µm from the edge of the imaging window or any areas of peripapillary atrophy.
• Nonsubfoveal lesion with border of GA lesion not encroaching center of the fovea. Distance of GA RPE lesion from center of the fovea >0 based on OCT imaging.
• Presence of any pattern of hyperautofluorescence based on FAF imaging in the junctional zone of GA. Absence of hyperautofluorescence (ie, pattern = none) is exclusionary.
• Documented evidence of vaccination within 5 years prior to screening, or willing to initiate vaccinations at least 14 days prior to dosing against:
• Streptococcus pneumoniae (with a pneumococcal conjugate vaccine 15 [PCV15] or 20 [PCV20] or with pneumococcal polysaccharide vaccine 23 [PPSV23]),
• Haemophilus influenzae (type B) (with Hib vaccine),
• Neisseria meningitidis types A, C, W, and Y (with a quadrivalent meningococcal conjugate vaccine [eg, Menactra or MenQuadfi]), and
• Neisseria meningitidis type B (with a meningococcal serogroup B vaccine [eg, Bexsero])
• Female participants must be:
• Women of non-childbearing potential (WONCBP), or
• Women of childbearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study (see Section 10.9.5.1)
• Male participants must be surgically sterile or must agree to use highly effective contraception from screening through the duration of the study
• Willing and able to provide informed consent and adhere to the study visit schedule and other protocol requirements

You may not qualify if…

• 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
• Clinically meaningful abnormalities on diagnostic and laboratory testing must be adjudicated by the sponsor's medical monitor and include:
• Cardiac
• Sustained resting heart rate outside of range of 40 to 100 beats/minute, or a heart rhythm that is not sinus rhythm, confirmed on repeat testing within a maximum of 30 minutes, at screening
• History or evidence of hereditary short QT syndrome
• Fridericia's corrected QT interval (QTcF) >480 milliseconds, or the PR interval outside the range of 120 to 220 milliseconds, confirmed on repeat testing within a maximum of 30 minutes at screening
• Any clinically relevant features of acute coronary syndrome (unstable angina, myocardial infarction)
• Any other ECG parameters outside of age-adjusted normative range
• Hepatic
• AST or ALT >1.3 × ULN
• Total bilirubin >1.1 × ULN
• Any 2 LFTs >1.1 × ULN
• Any other LFT parameters outside of age-adjusted normative range
• Renal
• Estimated glomerular filtration rate of less than <45 mL/min/m2 as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD- EPI) creatinine equation for adults
• Any other renal function parameters outside of age-adjusted normative range
• History or presence of malignancy (except history of basal or squamous cell carcinoma of the skin) that has not been successfully treated ≥1 year prior to enrollment
• History or presence of recurrent or unexplained infections, HIV infection, hepatitis B, hepatitis C, or meningococcal infection
• Participants with fever (defined as temperature >100.4 °F/38 °C) or any acute infection (including COVID-19 infection or infection requiring antibiotic treatment) within 30 days of screening until dosing
• Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
• Intention to donate sperm during this study or within 90 days after the last dose of study drug
• Prior administration of APL-3007

Where it is running

• Barnet Dulaney Perkins Eye Center (01018) — Mesa, Arizona, United States (enrolling)
• Associated Retina Consultants - Phoenix — Phoenix, Arizona, United States (enrolling)
• Retinal Research Institute, LLC (01021) — Phoenix, Arizona, United States (enrolling)
• Research Network Arizona — Scottsdale, Arizona, United States (enrolling)
• California Retina Consultants (CRC) - Bakersfield Office — Bakersfield, California, United States (enrolling)
• Retinal Diagnostic Center — Campbell, California, United States (enrolling)
• The Retina Partners - Encino — Encino, California, United States (enrolling)
• Retina Consultants of Orange County - Fullerton Office — Fullerton, California, United States (enrolling)
• Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034) — Huntington Beach, California, United States (enrolling)
• Salehi Retina Institute, Inc. Dba Retina Associates of Southern California (01034) — Huntington Beach, California, United States (enrolling)
• California Retina Consultants (01054) — Oxnard, California, United States (enrolling)
• Retina Consultants San Diego — Poway, California, United States (enrolling)
• Orange County Retina Medical Group — Santa Ana, California, United States (enrolling)
• Retina Macula Institute — Torrance, California, United States (enrolling)
• Bay Area Retina Associates - Walnut Creek — Walnut Creek, California, United States (enrolling)
• Colorado Retina Associates, PLLC — Lakewood, Colorado, United States (enrolling)
• Advanced Vision Research Institute — Longmont, Colorado, United States (enrolling)
• Connecticut Eye Consultants, PC (01074) — Danbury, Connecticut, United States (enrolling)
• ClearVista Clinical Research, LLC (01096) — Bayonet Point, Florida, United States (enrolling)
• Advance Retina Institute — Bonita Springs, Florida, United States (enrolling)
• Florida Retina Institute (01053) — Orlando, Florida, United States (enrolling)
• Florida Retina Institute - Orlando (01053) — Orlando, Florida, United States (enrolling)
• Retina Specialty Institute - Pensacola — Pensacola, Florida, United States (enrolling)
• Eye Associates of Pinellas (01020) — Pinellas Park, Florida, United States (enrolling)
• Associated Retina Consultants (01065) — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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