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QR-421a

Phase 1

Retinitis Pigmentosa | Small molecule | Rare Disease |ProQR Therapeutics N.V.|Last Updated: Apr 20, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

QR-421a · 1 trial · 8 indications

Phase 1 1
NCT03780257Study to Evaluate Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A GeneRetinitis Pigmentosa
COMPLETED20 Analytics
PHASE1COMPLETED
Study to Evaluate Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene
Retinitis PigmentosaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of ocular adverse events (AEs) in the treatment and contralateral eye
24 months

Incidence and severity of ocular AEs

Incidence and severity of non-ocular AEs
24 months

Secondary Endpoints

Change in DAC perimetry
24 months
Change in static perimetry
24 months
Change in EZ area by SD-OCT
24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QR-421aEXPERIMENTALSingle dose administration
Sham-procedure (dose cohort 1&2 only)SHAM_COMPARATORSham-procedure (no experimental drug administered)

Interventions

NameTypeDescription
QR-421aDRUGRNA antisense oligonucleotide for intravitreal injection
Sham-procedure (dose cohort 1&2 only)OTHERSham-procedure (no experimental drug administered)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Male or female, ≥ 18 years of age. 2. Clinical presentation consistent with RP with Usher syndrome type 2 or non-syndromic RP (NSRP), based on ophthalmic, audiologic, and vestibular examinations. 3. A molecular diagnosis of homozygosity or compound heterozygosity for 1 or mor...

Countries:United StatesCanadaFrance
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Frequently asked questions about QR-421a

What is QR-421a used for?

QR-421a is an investigational small molecule being developed for retinitis pigmentosa, a rare inherited retinal disease. It is being studied in patients with retinitis pigmentosa caused by mutations in exon 13 of the USH2A gene, including those with Usher syndrome type 2.

Who is developing QR-421a?

QR-421a is being developed by ProQR Therapeutics N.V., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PRQR. The company is focused on developing therapies for rare diseases.

What phase is QR-421a in?

QR-421a is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial evaluating its safety and tolerability has been completed.

What clinical trials is QR-421a in?

QR-421a has been studied in one completed Phase 1 clinical trial, identified as NCT03780257. This trial evaluated the safety and tolerability of QR-421a in 20 subjects with retinitis pigmentosa due to mutations in exon 13 of the USH2A gene.

Is QR-421a the same as any other drug?

QR-421a is the primary name for this investigational drug. No alternative names have been reported for this asset in clinical development.