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Gene Therapy

BIIB111 for Choroideremia & BIIB112 for X-Linked Retinitis Pigmentosa (SOLSTICE Trial)

Phase 3

Waitlist Available

Research Sponsored by NightstaRx Ltd, a Biogen Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

a. Have received a sub-retinal injection of BIIB112 for XLRP and have exited an antecedent study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111, with untreated control participants who have exited the STAR (NCT03496012) study. The trial will also compare BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112.

Who is the study for?

This trial is for individuals with Choroideremia (CHM) or X-linked Retinitis Pigmentosa (XLRP) who have previously received BIIB111 or BIIB112 treatments in earlier studies. Participants must have completed the prior research to be eligible.

What is being tested?

The study aims to assess the long-term safety and effectiveness of sub-retinal injections of BIIB111 for CHM and BIIB112 for XLRP by comparing previously treated participants with untreated controls from a related study.

What are the potential side effects?

While specific side effects are not listed, they may include typical reactions associated with sub-retinal injections such as eye discomfort, inflammation, possible vision changes, and risks associated with intraocular procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a BIIB112 injection for XLRP and completed a prior study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Assessment of Fundus Autofluorescence (AF) at Each Visit

Assessment of Fundus Photography at Each Visit

Assessment of Microperimetry at Each Visit

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: BIIB112Experimental Treatment1 Intervention

Participants previously treated with sub-retinal injection of BIIB112 in the antecedent study 274RP101 (NCT03116113) will be enrolled. This is a follow-up study, investigational product was administered in the previous study.

Group II: BIIB111Experimental Treatment1 Intervention

Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686) will be enrolled. Participants previously treated with this same sub-retinal injection (rAAV2-REP1) in antecedent studies 20150371 (NCT02553135), Pro00028599 (NCT02077361), THOR-TUE-01 (NCT02671539), CHM09/01 (NCT01461213) and REGEN2015 (NCT02407678) will also be invited for enrollment. This is a follow-up study, investigational product was administered in the previous study.

Group III: UntreatedActive Control1 Intervention

Untreated participants who served as controls in the antecedent study 273CH301 (NCT03496012), investigating treatment with BIIB111, will be enrolled. This is a follow-up study, participants will not be administered study medication nor receive a sham surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB111

2017

Completed Phase 3

~240

BIIB112

2017

Completed Phase 2

~50