Clinical trial • Phase III • Ophthalmology

BREPOCITINIB TOSILATE for Non-infectious uveitis | Intermediate uveitis | Posterior uveitis | Panuveitis

Phase III trial of BREPOCITINIB TOSILATE for Non-infectious uveitis | Intermediate uveitis | Posterior uveitis | Panuveitis.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Non-infectious uveitis | Intermediate uveitis | Posterior uveitis | Panuveitis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
25-02-2025

Trial design

Randomised, placebo tablet to match 45 mg brepocitinib tablet (matching placebo). auxiliary/rescue therapy: prednison (prednisone) available in 5 mg, 10 mg, 20 mg tablet formulations as auxiliary treatment.-controlled Phase III trial across 28 sites in Poland, Germany, Czechia and others.

Randomised
Yes
Comparator
Placebo tablet to match 45 mg brepocitinib tablet (matching placebo). Auxiliary/rescue therapy: Prednison (prednisone) available in 5 mg, 10 mg, 20 mg tablet formulations as auxiliary treatment.
Target Sample Size
105
Trial Duration For Participant
336

Eligibility

Recruits 105 Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial enrols adults aged 18–75 only. Informed consent is obtained from participants (no assent/child consent procedures are provided in the record). Country-specific ICFs and supporting documents are provided (see country ICF documents)..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial enrols adults aged 18–75 only. Informed consent is obtained from participants (no assent/child consent procedures are provided in the record). Country-specific ICFs and supporting documents are provided (see country ICF documents).

Inclusion criteria

  • {"criterion_text":"- Adult subjects (18-75 years old)\n- Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)\n- Active uveitic disease in at least 1 eye\n- Weight > 40 kg with a body mass index ≤ 40 kg/m2"}

Exclusion criteria

  • {"criterion_text":"- Has confirmed or suspected current diagnosis of infectious uveitis\n- 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 endpoints

  • {"endpoint_text":"- Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48","definition_or_measurement_approach":"Measured as time to treatment failure occurring on or after Period 1 Week 6 up to Period 1 Week 48."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24","definition_or_measurement_approach":"Proportion of participants who meet predefined treatment failure criteria occurring on or after Period 1 Week 6 up to Period 1 Week 24."}
  • {"endpoint_text":"- 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;","definition_or_measurement_approach":"Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 through Period 1 Week 24."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in central subfield retinal thickness in each eye from best state achieved at or prior to Period 1 Week 6 through Period 1 Week 24."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 through Period 1 Week 48."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in central subfield retinal thickness in each eye from best state achieved at or prior to Period 1 Week 6 through Period 1 Week 48."}

Recruitment

Planned Sample Size
105
Recruitment Window Months
36
Consent Approach
Informed consent is obtained from adult participants (18–75 years). Country-specific subject information and informed consent forms (L1_Main ICF) and related ICFs (pregnancy, pregnant partner, scout ICF, data privacy materials) are provided. Participant-facing documents are available in multiple country/languages (examples in the record: EN, DE, ES, PL, HU, IT, EL/GR, FR, NL, CZ). No assent process for minors is described (trial enrolls adults only).

Geography

Total Number Of Sites
28
Total Number Of Participants
105

Poland

Earliest CTIS Part Ii Submission Date
10-02-2025
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
175
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Ophthalmology
Contact Person Name
Dariusz Kęcik
Contact Person Email
Okulistyka.skd@uckwum.pl
Site Name
Warszawski Szpital Okulistyczny Sp. z o.o.
Department Name
Ophthalmology
Contact Person Name
Agnieszka Nowosielska
Contact Person Email
klinika@wszo.pl
Site Name
Optimum Profesorskie Centrum Okulistyki Sp. z o.o.
Department Name
Ophthalmology
Contact Person Name
Dorota Raczynska
Contact Person Email
draczynska@op.pl

Germany

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
283
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Ophthalmology
Contact Person Name
Matthias Mauschitz
Contact Person Email
Matthias.mauschitz@ukbonn.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Ophthalmology
Contact Person Name
Christophe Deuter
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Department Name
Opthalmology
Contact Person Name
Carsten Heinz
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Ophthalmology
Contact Person Name
Christoph Ehlken
Contact Person Email
Christoph.ehlken@uksh.de
Site Name
Medical Center - University Of Freiburg
Department Name
Ophthalmology
Contact Person Name
Thomas Ness
Site Name
Universitaet Muenster
Department Name
Ophthalmology
Contact Person Name
Nicole Eter
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Ophthalmology
Contact Person Name
Rainer Guthoff

Czechia

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
262
Number Of Sites
1
Number Of Participants
14

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Ophthalmology
Contact Person Name
Jarmila Heissigerova
Contact Person Email
jarmila.heissigerova@vfn.cz

Spain

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
291
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Ophthalmology
Contact Person Name
Alfredo Adán
Contact Person Email
amadan@clinic.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Ophthalmology
Contact Person Name
Julia Sanchez Quiros
Site Name
Bellvitge University Hospital
Department Name
Ophthalmology
Contact Person Name
Pere Garcia Bru
Site Name
Hospital Universitari Vall D Hebron
Department Name
Ophthalmology
Contact Person Name
Eric Kirkegaard Biosca
Contact Person Email
Eric.Kirkegaard@vallhebron.cat

Hungary

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
344
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
University Of Szeged
Department Name
Ophthalmology
Contact Person Name
Edit Toth-Molnár
Site Name
University Of Debrecen
Department Name
Ophthalmology
Contact Person Name
Mariann Fodor
Contact Person Email
mfodor@med.unideb.hu
Site Name
University Of Pecs
Department Name
Ophthalmology
Contact Person Name
Adrienne Csutak
Contact Person Email
Csutak.adrienne@pte.hu
Site Name
Semmelweis University
Department Name
Ophthalmology
Contact Person Name
Zoltán Nagy

Italy

Earliest CTIS Part Ii Submission Date
18-02-2025
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
302
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Ophthalmology
Contact Person Name
Elisabetta Miserocchi
Contact Person Email
Miserocchi.elisabett@unisr.it
Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
UR Retina Medica
Contact Person Name
Daniel De Geronimo
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Ocular Immunology
Contact Person Name
Luca Cimino
Contact Person Email
Luca.cimino@ausl.re.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Ophthalmology
Contact Person Name
Luca Rossetti
Contact Person Email
Luca.rossetti@unimi.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Opthamology
Contact Person Name
Barbara Iaccheri

Austria

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
274
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical University Of Vienna
Department Name
Ophthalmology
Contact Person Name
Marion Funk
Contact Person Email
Marion.funk@meduniwien.ac.at
Site Name
Johannes Kepler University Linz
Department Name
Ophthalmology & Optometry
Contact Person Name
Matthias Bolz

Belgium

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
271
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
UZ Leuven
Department Name
Ophthalmology
Contact Person Name
Joachim Van Calster
Contact Person Email
joachim.vancalster@uzleuven.be

Greece

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
321
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
General University Hospital Of Larissa
Department Name
Ophthalmology
Contact Person Name
Sofia Androudi
Contact Person Email
androudi@otenet.gr

Sponsor

Primary sponsor

Full Name
Priovant Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PRA Hellas CRO A.E.
Name
Icon Public Limited Company
Name
Iqvia Biotech LLC
Name
PPD Global Central Labs

Third parties

  • {"country":"United States","full_name":"Duke Reading Center","duties_or_roles":"Central reader for ophthalmology images","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"PK sample storage and testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement services","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"BCVA certifications for site staff","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
brepocitinib
Active Substance
BREPOCITINIB TOSILATE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Not authorised (investigational)
Maximum Dose
45 mg daily
Investigational Product Name
Placebo tablet to match 45 mg brepocitinib tablet.
Modality
Other
Authorisation Status
Not authorised (placebo for matched dose)
Investigational Product Name
Prednison 5 mg GALEN® Tabletten
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorised
Dose Levels
5 mg
Maximum Dose
60 mg daily
Investigational Product Name
Prednison 10 mg GALEN®
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorised
Dose Levels
10 mg
Maximum Dose
60 mg daily
Investigational Product Name
Prednison 20 mg GALEN®
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Marketing authorised
Dose Levels
20 mg
Maximum Dose
60 mg daily

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