Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

ADARx Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 2

Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration

Treatments: Drug: Placebo; Drug: ADX-038

Study type: Interventional

Funder types: Industry

Identifiers

NCT06990269

ADX-038-202

Details and patient eligibility

About

Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.

Enrollment: 240 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of GA of the macula secondary to AMD
• GA lesions between 2.5 and 12.5 mm2 at screening
• Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
• Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Exclusion criteria

• Has GA secondary to causes other than AMD
• Has active ocular disease that compromises or confounds visual function
• History of surgery for retinal detachment
• Has ocular condition other than GA secondary to AMD
• Use of intravitreal complement inhibitors in study eye
• Hereditary or acquired complement deficiency
• Active viral, bacterial or fungal infection
• Liver injury as evidenced by abnormal liver function tests
• Donating blood
• History of choroidal neovascularization in the study eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Active - ADX-038

Experimental group

Description:

Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.

Treatment:

Drug: ADX-038

Placebo - Saline

Placebo Comparator group

Description:

Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.

Treatment:

Drug: Placebo