botaretigene sparoparvovec

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botaretigene sparoparvovec

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Ongoing Clinical Trials

Last Updated: 09/24/2024

SUMMARY

The table below provides a listing of ongoing clinical trials for botaretigene sparoparvovec (JNJ-74765340; AAV2-RPGR; AAV5-RPGR; AAV5-hRKp.RPGR).¹^-³
This product is currently an investigational agent and is not approved for any use. Information contained in this response is not intended as an endorsement of any usage of this investigational product.
For information on ongoing clinical trials for botaretigene sparoparvovec, please visit www.clinicaltrials.gov.

ongoing clinical trials

Ongoing Clinical Trials for Botaretigene Sparoparvovec (JNJ-74765340; AAV2-RPGR; AAV5-RPGR; AAV5-hRKp.RPGR).¹^-³

NCT Identifier	Study Title	Status
NCT04671433 ³	Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR Gene	Ongoing
NCT04794101 ⁴	Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene	Ongoing
NCT03252847 ²	An Open Label, Multi-Center, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2-RPGR) for Gene Therapy of Adults and Children With X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)	Completed
NCT04312672 ⁵	Long-Term Follow-Up Study of Participants Following an Open Label, Multi-Center, Phase I/II Dose Escalation Trial of a Recombinant Adeno-Associated Virus Vector (AAV5-hRKp.RPGR) for Gene Therapy of Adults and Children With X-Linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulatory (RPGR)	Ongoing
NCT05926583 ⁶	Phase 3 Study to Evaluate the Safety and Efficacy of AAV5-hRKp.RPGR for the Treatment of Japanese X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)	Ongoing
Abbreviations: AAV2, adeno-associated virus 2; AAV5, adeno-associated virus 5; hRKp, human rhodopsin kinase promoter; RPGR, retinitis pigmentosa GTPase regulator.

References

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1	Janssen to Highlight Innovation in Retinal Pipeline at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting. Accessed 2023-09-26. Available via: https://www.jnj.com/janssen-to-highlight-innovation-in-retinal-pipeline-at-the-association-for-research-in-vision-and-ophthalmology-arvo-2023-annual-meeting
2	MeiraGTx UK II Ltd. Gene therapy for X-linked retinitis pigmentosa (XLRP) retinitis pigmentosa GTPase regulator (RPGR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2017- [cited 2021 October 26]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03252847 NLM Identifier: NCT03252847.
3	Janssen Research & Development, LLC. Gene therapy trial for the treatment of X-linked retinitis pigmentosa associated with variants in the RPGR gene. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2021 October 14]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04671433 NLM Identifier: NCT04671433.
4	Janssen Research & Development, LLC. Follow-up gene therapy trial for the treatment of X-linked retinitis pigmentosa associated with variants in the RPGR gene. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2021- [cited 2021 October 14]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04794101 NLM Identifier: NCT04794101.
5	Janssen Research & Development, LLC. Long term follow-up gene therapy study for XLRP RPGR. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020- [cited 2021 October 26]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04312672 NLM Identifier: NCT04312672.
6	Janssen Pharmaceutical K.K. A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 April 25]. Available from: https://clinicaltrials.gov/study/NCT05926583 NLM Identifier: NCT05926583.