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

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NightstaRx Ltd, a Biogen Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The objective of the study is to evaluate 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 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR (NCT03496012) study and BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112 and who have exited an antecedent study.

Eligibility Criteria

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.

Inclusion Criteria

You have previously taken part in a study where a medicine called BIIB111 was injected into your eye for a condition called CHM, and you have completed that study.

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

The study is not open to people with X-linked retinitis pigmentosa (XLRP).

+1 more

Participant Groups

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.

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.