REGENXBIO Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2025-11-25: Study NCT07236606; Company role Lead sponsor; Phase Phase 3; Status Active not recruiting.
- 2025-03-18: Study NCT06942520; Company role Collaborator; Phase Phase 2; Status Recruiting.
- 2024-05-08: Study NCT06491927; Company role Lead sponsor; Phase Observational; Status Enrolling by invitation.
- 2023-07-24: Study NCT06103487; Company role Lead sponsor; Phase Observational; Status Enrolling by invitation.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2025-11-25 | NCT07236606 RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome) | Lead sponsor | Phase 3 | Active not recruiting | MPS II; Hunter Syndrome (MPS II) | 2 | 2031-05-30 |
| 2025-03-18 | NCT06942520 Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME) | Collaborator Lead: Sierra Eye Associates | Phase 2 | Recruiting | Diabetic Macular Edema | 18 | 2027-12 |
| 2024-05-08 | NCT06491927 Long Term Follow-up for RGX-202 | Lead sponsor | Observational | Enrolling by invitation | Duchenne Muscular Dystrophy | 66 | 2029-12-01 |
| 2023-07-24 | NCT06103487 Long Term Follow-Up for RGX-111 | Lead sponsor | Observational | Enrolling by invitation | Mucopolysaccharidosis I | 21 | 2027-09 |
| 2023-01-04 | NCT05693142 AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD) | Lead sponsor | Phase 2, Phase 3 | Active not recruiting | Duchenne Muscular Dystrophy | 65 | 2028-06 |
| 2022-12-20 | NCT05683379 AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD | Lead sponsor | Observational | Active not recruiting | Duchenne Muscular Dystrophy | 200 | 2026-09 |
| 2022-04-04 | NCT05296447 Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy | Collaborator Lead: AbbVie | Phase 2 | Enrolling by invitation | Diabetic Retinopathy, DR | 100 | 2031-06 |
| 2022-03 | NCT04591834 Mucopolysaccharidosis Type II Observational | Lead sponsor | Observational | Withdrawn | Mucopolysaccharidosis II | 0 | 2025-07 |
| 2022-01-13 | NCT05407636 Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD | Collaborator Lead: AbbVie | Phase 3 | Active not recruiting | AMD; nAMD; Wet Age-related Macular Degeneration; wAMD; WetAMD; CNV | 735 | 2027-11 |
| 2021-12-20 | NCT05210803 Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD | Collaborator Lead: AbbVie | Phase 2 | Enrolling by invitation | Neovascular Age-Related Macular Degeneration (nAMD) | 116 | 2031-07 |
| 2021-03-31 | NCT04480476 A Retrospective, Natural History Study in Children With CLN2 | Lead sponsor | Observational | Withdrawn | Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) | 0 | 2022-04 |
| 2021-03-31 | NCT04462692 An Observational Study in Children With CLN2 Batten Disease | Lead sponsor | Observational | Withdrawn | Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) | 0 | 2023-10 |
| 2021-03-14 | NCT04597385 Long-term Follow-Up for RGX-121 | Lead sponsor | Observational | Active not recruiting | Mucopolysaccharidosis II | 27 | 2028-10 |
| 2021-03-11 | NCT04571970 RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome) | Lead sponsor | Phase 1, Phase 2 | Completed | Mucopolysaccharidosis Type II (MPS II) | 6 | 2024-05-23 |
| 2020-12-29 | NCT04704921 Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD | Collaborator Lead: AbbVie | Phase 2, Phase 3 | Active not recruiting | AMD; nAMD; Wet Age-related Macular Degeneration; wAMD; Wet AMD; CNV; Neovascular AMD; Neovascular Age-related Macular Degeneration; Choroidal Neovascularization | 671 | 2027-11 |
| 2020-11-20 | NCT04567550 RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) | Collaborator Lead: AbbVie | Phase 2 | Active not recruiting | Diabetic Retinopathy (DR); Center-Involved Diabetic Macular Edema (CI-DME) | 139 | 2026-12 |
| 2020-08-25 | NCT04514653 RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) | Collaborator Lead: AbbVie | Phase 2 | Active not recruiting | Neovascular Age-Related Macular Degeneration (nAMD) | 146 | 2027-02 |
| 2019-12-04 | NCT04148001 Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients | Lead sponsor | Observational | Completed | Homozygous Familial Hypercholesterolemia (HoFH) | 4 | 2020-04-08 |
| 2019-09-30 | NCT04080050 A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501 | Lead sponsor | Observational | Unknown | Homozygous Familial Hypercholesterolemia (HoFH) | 8 | 2025-09-29 |
| 2019-04-03 | NCT03580083 RGX-111 Gene Therapy in Patients With MPS I | Lead sponsor | Phase 1, Phase 2 | Suspended | Mucopolysaccharidosis Type I (MPS I); Hurler Syndrome; Hurler-Scheie Syndrome | 21 | 2029-03-06 |
| 2018-09-27 | NCT03566043 CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome) | Lead sponsor | Phase 2, Phase 3 | Active not recruiting | Mucopolysaccharidosis Type II (MPS II) | 48 | 2025-08 |
| 2017-09-27 | NCT03529786 Mucopolysaccharidosis Type II Natural History | Lead sponsor | Observational | Completed | Mucopolysaccharidosis II | 36 | 2022-03-22 |
| 2017-03-29 | NCT03066258 Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Neovascular Age-related Macular Degeneration; Wet Age-related Macular Degeneration | 42 | 2021-06-17 |
| 2016-03 | NCT02651675 A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH) | Lead sponsor | Phase 1, Phase 2 | Terminated Results posted | Homozygous Familial Hypercholesterolemia (HoFH) | 9 | 2020-11-27 |
| NCT07652606 Expanded Access to RGX-202 | Lead sponsor | Expanded_access | Temporarily not available |
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