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ClinicalTrials.gov public records Last synced Sep 30, 2026, 5:15 PM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: REGENXBIO Inc. Clear all
Completed Phase 1Phase 2 Interventional

RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)

NCT04571970
View directory record Official record
Conditions
Mucopolysaccharidosis Type II (MPS II)
Interventions
RGX-121
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
5 Years to 17 Years · Male only
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Oakland, California
Source: ClinicalTrials.gov public record
Updated Jan 28, 2025 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 3 Interventional

RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)

NCT07236606
View directory record Official record
Conditions
MPS II, Hunter Syndrome (MPS II)
Interventions
RGX-121-3102
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
4 Months to 5 Years · Male only
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
1
States / cities
New Brunswick, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 2 Interventional

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)

NCT04514653
View directory record Official record
Conditions
Neovascular Age-Related Macular Degeneration (nAMD)
Interventions
Ranibizumab, ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2, ABBV-RGX-314 Dose 3, Local Steroid, Topical Steroid, ABBV-RGX-314 Dose 4
Biological · Genetic · Drug
Lead sponsor
AbbVie
Industry
Eligibility
50 Years to 89 Years
Enrollment
146 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
18
States / cities
Phoenix, Arizona • Bakersfield, California • Beverly Hills, California + 15 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Not listed No phase listed Observational

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501

NCT04080050
View directory record Official record
Conditions
Homozygous Familial Hypercholesterolemia (HoFH)
Interventions
Single intravenous (IV) dose of human Low Density Lipoprotein Receptor (LDLR) Gene Therapy
Drug
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
4
States / cities
Columbus, Ohio • Portland, Oregon • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 9, 2023 · Synced Sep 30, 2026, 5:15 PM EDT
Temporarily Not Available No phase listed Expanded access

Expanded Access to RGX-202

NCT07652606
View directory record Official record
Conditions
Not listed
Interventions
RGX-202
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
Not listed
U.S. locations
1
States / cities
Rockville, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 17, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 2 Interventional

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)

NCT04567550
View directory record Official record
Conditions
Diabetic Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME)
Interventions
ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2, ABBV-RGX-314 Dose 3, Topical Steroid, ABBV-RGX-314 Dose 4, Aflibercept
Genetic · Drug · Biological
Lead sponsor
AbbVie
Industry
Eligibility
25 Years to 89 Years
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
25
States / cities
Phoenix, Arizona • Bakersfield, California • Beverly Hills, California + 21 more
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Completed No phase listed Observational

Mucopolysaccharidosis Type II Natural History

NCT03529786
View directory record Official record
Conditions
Mucopolysaccharidosis II
Interventions
Not listed
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
Male only
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 26, 2022 · Synced Sep 30, 2026, 5:15 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial

NCT03066258
View directory record Official record
Conditions
Neovascular Age-related Macular Degeneration, Wet Age-related Macular Degeneration
Interventions
RGX-314
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
50 Years to 89 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
8
States / cities
Santa Barbara, California • Baltimore, Maryland • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated May 16, 2023 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)

NCT03566043
View directory record Official record
Conditions
Mucopolysaccharidosis Type II (MPS II)
Interventions
RGX-121
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
4 Months to 5 Years · Male only
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
4
States / cities
Oakland, California • New Brunswick, New Jersey • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 28, 2025 · Synced Sep 30, 2026, 5:15 PM EDT
Enrolling by invitation No phase listed Observational

Long Term Follow-Up for RGX-111

NCT06103487
View directory record Official record
Conditions
Mucopolysaccharidosis I
Interventions
No Intervention
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
Not listed
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)

NCT02651675
View directory record Official record
Conditions
Homozygous Familial Hypercholesterolemia (HoFH)
Interventions
AAV directed hLDLR gene therapy
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
5
States / cities
Boca Raton, Florida • Kansas City, Kansas • Portland, Oregon + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2023 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)

NCT05693142
View directory record Official record
Conditions
Duchenne Muscular Dystrophy
Interventions
RGX-202
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
1 Year and older · Male only
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
19
States / cities
Little Rock, Arkansas • Orange, California • Palo Alto, California + 16 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Enrolling by invitation No phase listed Observational

Long Term Follow-up for RGX-202

NCT06491927
View directory record Official record
Conditions
Duchenne Muscular Dystrophy
Interventions
No Intervention
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
Male only
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
5
States / cities
Little Rock, Arkansas • Palo Alto, California • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 24, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Enrolling by invitation Phase 2 Interventional

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

NCT05296447
View directory record Official record
Conditions
Diabetic Retinopathy, DR
Interventions
Standard of Care, Aflibercept
Drug
Lead sponsor
AbbVie
Industry
Eligibility
Not listed
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2031
U.S. locations
20
States / cities
Phoenix, Arizona • Bakersfield, California • Beverly Hills, California + 17 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Completed No phase listed Observational

Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients

NCT04148001
View directory record Official record
Conditions
Homozygous Familial Hypercholesterolemia (HoFH)
Interventions
Not listed
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Boca Raton, Florida
Source: ClinicalTrials.gov public record
Updated Feb 2, 2021 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting No phase listed Observational

Long-term Follow-Up for RGX-121

NCT04597385
View directory record Official record
Conditions
Mucopolysaccharidosis II
Interventions
Long-term Follow-Up
Other
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
Male only
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
3
States / cities
San Francisco, California • New Brunswich, New Jersey • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

NCT04704921
View directory record Official record
Conditions
AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, Wet AMD, CNV, Neovascular AMD, Neovascular Age-related Macular Degeneration, Choroidal Neovascularization
Interventions
ABBV-RGX-314, Ranibizumab (LUCENTIS®)
Genetic · Biological
Lead sponsor
AbbVie
Industry
Eligibility
50 Years to 89 Years
Enrollment
671 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
89
States / cities
Phoenix, Arizona • Sun City, Arizona • Little Rock, Arkansas + 77 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Recruiting Phase 2 Interventional

Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

NCT06942520
View directory record Official record
Conditions
Diabetic Macular Edema
Interventions
RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept (2.0 mg)
Genetic · Biological
Lead sponsor
Sierra Eye Associates
Other
Eligibility
25 Years to 89 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Reno, Nevada
Source: ClinicalTrials.gov public record
Updated Apr 24, 2025 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting Phase 3 Interventional

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

NCT05407636
View directory record Official record
Conditions
AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, WetAMD, CNV
Interventions
ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2, Aflibercept (EYLEA®)
Genetic · Biological
Lead sponsor
AbbVie
Industry
Eligibility
50 Years to 89 Years
Enrollment
735 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
107
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Bakersfield, California + 94 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Suspended Phase 1Phase 2 Interventional

RGX-111 Gene Therapy in Patients With MPS I

NCT03580083
View directory record Official record
Conditions
Mucopolysaccharidosis Type I (MPS I), Hurler Syndrome, Hurler-Scheie Syndrome
Interventions
RGX-111
Genetic
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
4 Months and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2029
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Mar 12, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Enrolling by invitation Phase 2 Interventional

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

NCT05210803
View directory record Official record
Conditions
Neovascular Age-Related Macular Degeneration (nAMD)
Interventions
Standard of Care, Ranibizumab
Drug
Lead sponsor
AbbVie
Industry
Eligibility
Not listed
Enrollment
116 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
16
States / cities
Phoenix, Arizona • Bakersfield, California • Beverly Hills, California + 13 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Active, not recruiting No phase listed Observational

AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD

NCT05683379
View directory record Official record
Conditions
Duchenne Muscular Dystrophy
Interventions
AAV8 DetectCDx
Diagnostic Test
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
0 Years to 25 Years · Male only
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 30, 2026, 5:15 PM EDT
Withdrawn No phase listed Observational

Mucopolysaccharidosis Type II Observational

NCT04591834
View directory record Official record
Conditions
Mucopolysaccharidosis II
Interventions
Observational
Other
Lead sponsor
REGENXBIO Inc.
Industry
Eligibility
1 Month to 8 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
2
States / cities
Oakland, California • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 10, 2022 · Synced Sep 30, 2026, 5:15 PM EDT