Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 6:22 PM
Study NCT ID:
NCT06990269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D034741', 'term': 'RNA, Small Interfering'}], 'ancestors': [{'id': 'D016372', 'term': 'RNA, Antisense'}, {'id': 'D016375', 'term': 'Antisense Elements (Genetics)'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012313', 'term': 'RNA'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D058727', 'term': 'RNA, Small Untranslated'}, {'id': 'D022661', 'term': 'RNA, Untranslated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Masked, Placebo-Controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of ADX-038 on the preservation of the EZ layer', 'timeFrame': '12 months', 'description': 'Rate of change in the area of total EZ loss in the study eye from baseline to Month 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geographic Atrophy Secondary to Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of GA of the macula secondary to AMD\n* GA lesions between 2.5 and 12.5 mm2 at screening\n* Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n* 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\n\nExclusion Criteria:\n\n* Has GA secondary to causes other than AMD\n* Has active ocular disease that compromises or confounds visual function\n* History of surgery for retinal detachment\n* Has ocular condition other than GA secondary to AMD\n* Use of intravitreal complement inhibitors in study eye\n* Hereditary or acquired complement deficiency\n* Active viral, bacterial or fungal infection\n* Liver injury as evidenced by abnormal liver function tests\n* Donating blood\n* History of choroidal neovascularization in the study eye'}, 'identificationModule': {'nctId': 'NCT06990269', 'briefTitle': 'Phase 2 Study of ADX-038 in Participants With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADARx Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'ADX-038-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active - ADX-038', 'description': 'Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.', 'interventionNames': ['Drug: ADX-038']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Saline', 'description': 'Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ADX-038', 'type': 'DRUG', 'otherNames': ['siRNA'], 'description': 'siRNA duplex oligonucleotide', 'armGroupLabels': ['Active - ADX-038']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline', 'armGroupLabels': ['Placebo - Saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lisa Melia, MA', 'role': 'CONTACT', 'email': 'lmelia@adarx.com', 'phone': '877-232-7974'}], 'overallOfficials': [{'name': 'Nora Dimon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADARx Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADARx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}