A Phase 3 Study of Brepocitinib in Adults with Active, Non-Infectious, Non-Anterior Uveitis (CLARITY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Priovant Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

28 Feb 2025 → ongoing

Decision date (initial)

2025-02-28

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Priovant Therapeutics, Inc.

External identifiers

EU CT number

2024-515089-15-00

ClinicalTrials.gov

NCT06431373

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To evaluate the efficacy of brepocitinib in participants with non-infectious intermediate uveitis, posterior uveitis, and panuveitis

Secondary objectives 1

1. To further evaluate the efficacy of brepocitinib in participants with non-infectious intermediate uveitis, posterior uveitis, and panuveitis

Conditions and MedDRA coding

active non-infectious uveitis (intermediate uveitis, posterior uveitis, panuveitis)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult subjects (18-75 years old)
2. Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
3. Active uveitic disease in at least 1 eye
4. Weight > 40 kg with a body mass index ≤ 40 kg/m2

Exclusion criteria 2

1. Has confirmed or suspected current diagnosis of infectious uveitis
2. History of or have: - Lymphoproliferative disorder; - active malignancy; - cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.); - Thrombosis or cerebrovascular ischemic event within the last 12 months; - a high risk for herpes zoster reactivation; - active or recent infections

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48

Secondary endpoints 5

1. Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24
2. Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24;
3. Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24
4. Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48
5. Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Priovant Therapeutics Inc.

Sponsor organisation

Priovant Therapeutics Inc.

Address

151 West 42nd Street Floor 15

City

New York

Postcode

10036-6631

Country

United States

Scientific contact point

Organisation

Priovant Therapeutics Inc.

Contact name

Clinical Trial Administrator

Public contact point

Organisation

Priovant Therapeutics Inc.

Contact name

Clinical Trial Administrator

Third parties 13

Locations

9 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 181 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications