Clinical trial • Phase II • Immunology|Ophthalmology

SIBEPRENLIMAB for Sjögren's syndrome

Phase II trial of SIBEPRENLIMAB for Sjögren's syndrome.

Overview

Trial Therapeutic Area
Immunology|Ophthalmology
Trial Disease
Sjögren's syndrome
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
22-04-2025

Trial design

Randomised, sibeprenlimab placebo (placebo arm); dose and schedule not specified in the provided record-controlled Phase II trial in Germany, Spain, Romania and others.

Randomised
Yes
Comparator
Sibeprenlimab placebo (placebo arm); dose and schedule not specified in the provided record
Target Sample Size
40
Trial Duration For Participant
196

Eligibility

Recruits 40 Vulnerable population selected. Participants must provide signed written informed consent prior to any trial procedures; inclusion criteria state ability to provide written informed consent and ability to comply with trial requirements (as judged by the principal investigator). All participants are adults (18-75). No information on assent procedures for minors is provided..

Pregnancy Exclusion
Pregnant or nursing (lactating) women
Vulnerable Population
Vulnerable population selected. Participants must provide signed written informed consent prior to any trial procedures; inclusion criteria state ability to provide written informed consent and ability to comply with trial requirements (as judged by the principal investigator). All participants are adults (18-75). No information on assent procedures for minors is provided.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the trial\n- Participants taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day prednisone/prednisolone or equivalent for at least 30 days before randomization\n- Ability to provide written informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial\n- Participants between 18 to 75 years of age\n- Classification of Sjögren’s disease according to the 2016 American College of Rheumatology (ACR)/EULAR criteria\n- Seropositive for anti-Ro52 and/or anti-Ro60 antibodies at screening\n- Screening ESSDAI score ≥ 5; activity in the pulmonary, central nervous system, or peripheral nervous system domains will not be counted towards the qualifying screening ESSDAI score\n- Stimulated whole salivary flow rate of ≥ 0.05 mL/min at screening\n- Serum IgG > 900 mg/dL as assessed prospectively by a central laboratory test\n- Ability to communicate well with the investigator, understand and agree to comply with the requirements of the trial\n- Participants may be on hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week), leflunomide (≤ 20 mg daily), or azathioprine (≤ 150 mg/day) if the participant has been on a stable and well-tolerated dose for at least 30 days before randomization"}

Exclusion criteria

  • {"criterion_text":"- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness\n- Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the trial\n- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result\n- History of malignancy of any organ system (other than basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases\n- Any history of head and neck radiation treatment\n- History of sarcoidosis\n- Presence of active fibromyalgia\n- Participant has uncontrolled type 2 diabetes, as evidenced by a screening hemoglobin A1c (HbA1c) value > 8%. Participant will be excluded if their antidiabetic regimen is not stable. A stable antidiabetic regimen is defined as either diet and exercise therapy alone or in combination with any approved antidiabetic medication in which the doses of oral or noninsulin injectable medications have not changed during the 8 weeks prior to enrollment; or the doses of long-acting insulin or intermediate-acting insulin have not varied by more than 20% during the 8 weeks prior to enrollment\n- Any surgical, medical (eg, uncontrolled hypertension, heart failure, cerebrovascular accident), psychiatric or additional physical condition that the sponsor, medical monitor, and/or investigator feels may jeopardize the participant in case of participation in this trial\n- Positive serology for hepatitis B surface antigen\n- Hepatitis C: participants with positive hepatitis C antibody and hepatitis C virus (HCV)-ribonucleic acid (RNA) at screening are excluded. Chronic hepatitis C participants who have completed HCV antiviral treatment must be HCV-RNA negative at least 12 weeks after treatment before randomization to be eligible. Cases of spontaneous HCV clearance should be discussed with the sponsor before enrollment\n- Prior use of a B-cell depleting therapy within 12 months prior to randomization; if the CD19 count has returned to the baseline value prior to receipt of the B-cell depleting therapy, or at a normal reference value, as early as 9 months since the therapy, the patient may be eligible if the B-cell count is greater than: the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is greater) at screening\n- Evidence of active tuberculosis infection is exclusionary. Participant with previously treated tuberculosis and previously treated or newly diagnosed latent tuberculosis may be eligible\n- Pregnant or nursing (lactating) women\n- Participants with a known history of noncompliance to medication, or who were unable or unwilling to complete patient-reported outcome questionnaires, or who are unable or unwilling to use the device for collection of patient-reported outcomes\n- Heterosexually active biological males or participants of childbearing potential, or their partners, who do not agree to adhere to use 2 forms of highly effective contraceptives from the time of consent through the end of the participant’s participation in the trial and for an additional 90 days (biological male participants) or 30 days (biological female participants) thereafter\n- Biological male participants who do not agree to avoid donation of sperm from the time of consent through the end of the participant’s participation in the trial and an additional 90 days thereafter\n- Participant who has a recent history (ie, within the past year) of alcohol or drug/chemical abuse that would, based on the investigator’s clinical judgment, interfere with the participant’s ability to participate in the trial\n- Participant is judged by the investigator or the medical monitor to be inappropriate for the trial\n- Participants who would be likely to require prohibited concomitant therapy during the trial\n- Prior treatment with any of the following within 6 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis; intravenous (IV) or oral cyclophosphamide, mycophenolate mofetil, IV or oral cyclosporine A or any other immunosuppressants not specified in the protocol\n- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer\n- Any one of the following laboratory values at screening. Hematologic abnormalities below these reference values will be reviewed by the Medical Monitor and investigator to determine whether the values are attributable to Sjögren’s disease. If the abnormalities are attributable to Sjögren’s disease, the participant may be enrolled. a) Hemoglobin levels < 8.0 g/dL b) White blood cells (WBC) count < 4.0 × 103/μL c) Platelet count < 100 × 103/μL d) Absolute neutrophil count (ANC) < 1.0 × 103/μL e) eGFR calculated using the 2021 Chronic Kidney Disease-Epidemiology Collaboration serum creatinine eGFR formula < 45 mL/min/1.73 m2\n- Active viral, bacterial, or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection\n- History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the sibeprenlimab SC injection formulation\n- History of major organ, hematopoietic stem cell, or bone marrow transplant\n- Regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to screening, or any anticipated change in the treatment regimen during the course of the trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in ESSDAI score at 28 weeks","definition_or_measurement_approach":"Change from baseline in ESSDAI score at 28 weeks (ESSDAI measured at baseline and at Week 28)"}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in ESSPRI score at 28 weeks\n- Incidence of TEAEs graded by severity, injection site reactions, clinical laboratory tests, vital sign measurements, and physical examinations\n- Proportion of participants with minimal clinical improvement at 28 weeks defined as ESSDAI reduction ≥ 3 points from baseline\n- Proportion of participants with minimal clinical improvement at 28 weeks defined as ESSPRI reduction ≥ 1 point from baseline\n- Change from baseline in individual ESSDAI domains at 28 weeks\n- Change from baseline at 28 weeks in the: Salivary flow rate Tear flow rate\n- Change from baseline at 28 weeks for the following: ClinESSDAI score PhGA score of disease activity PaGA score of participant outcomes FACIT-Fatigue score SF-36v2 Physical Component Summary Scale score and Mental Component Summary Scale score Patient-reported Sjögren’s disease diary score (symptom and impact)\n- Proportion of participants with minimal clinical improvement, defined as FACIT-Fatigue score increase of ≥ 4 from baseline, at 28 weeks\n- Time to the first occurrence of minimal clinical improvement in ESSDAI by Week 28\n- Time to the first occurrence of minimal clinical improvement in ESSPRI by Week 28\n- Percent change from baseline to Week 28 in total serum IgA, IgG, IgM, and free APRIL concentrations\n- Evaluation of PK profile\n- Evaluation of serum ADA","definition_or_measurement_approach":"Endpoints are defined in-protocol as listed (e.g., ESSDAI/ESSPRI change at Week 28; proportion thresholds defined where specified such as ESSDAI reduction ≥3, ESSPRI reduction ≥1, FACIT-Fatigue increase ≥4). Safety measured by incidence of TEAEs, injection site reactions, labs, vitals and physical exams. PK and ADA evaluated by serum assays."}

Recruitment

Registry Or Advocacy Recruitment
True, Sjoegren'S Foundation Inc.
Planned Sample Size
40
Recruitment Window Months
29
Consent Approach
Written informed consent required from participants prior to any trial-specific procedures; inclusion criteria require 'Signed informed consent must be obtained prior to participation in the trial' and ability to provide written informed consent. Participants are adults (18-75). Subject information and informed consent forms (ICFs) are available in multiple country-specific versions (documents listed for German, Spanish, Romanian, Bulgarian, Greek, Polish and English-language ICFs). No assent procedures for minors are provided (trial enrols adults only).

Geography

Total Number Of Sites
37
Total Number Of Participants
40

Germany

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
154
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Contact Person Name
Philipp Köhler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Stephanie Finzel
Site Name
Medicover GmbH
Contact Person Name
David Kofler
Contact Person Email
david.kofler@medicover.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik IV - Sektion Rheumatologie und klinische Immunologie
Contact Person Name
Hendrik Schulze-Koops

Spain

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
198
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Hospital Universitario De Torrevieja
Department Name
Rheumatology
Contact Person Name
Angel Garcia Manzanares
Contact Person Email
garcia_angman@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Rheumatology
Contact Person Name
Carlos Guillen Astete
Contact Person Email
caranguillen@gmail.com
Site Name
Hospital General Universitario De Castellon
Department Name
Rheumatology
Contact Person Name
Arantxa Conesa Mateos
Contact Person Email
conesa_ara@gva.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Rheumatology
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es

Romania

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
251
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Rheumatology
Contact Person Name
Simona Rednic
Contact Person Email
srednic@umfcluj.ro
Site Name
Saint Maria Hospital
Department Name
Rheumatology
Contact Person Name
Florian Berghea
Contact Person Email
berghea1@gmail.com
Site Name
Medaudio-Optica S.R.L.
Department Name
Rheumatology
Contact Person Name
Razvan Constantin Ionitescu
Contact Person Email
razvan1us@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Rheumatology
Contact Person Name
Razvan-Adrian Ionescu
Contact Person Email
tane67@gmail.com
Site Name
Selfmed Clinique S.R.L.
Department Name
Rheumatology
Contact Person Name
Viorica Crisan
Contact Person Email
viocrisan2002@yahoo.com

Bulgaria

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
150
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Medical Center Excelsior OOD
Department Name
Clinic of Rheumatology
Contact Person Name
Tzvetanka Petranova
Contact Person Email
dr_petranova@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Contact Person Name
Krasimir Kraev
Contact Person Email
dr.krasimir.kraev@gmail.com
Site Name
Medcenter Nova Clinic Ltd.
Contact Person Name
Dobromir Staykov
Contact Person Email
dobromirstajkov@abv.bg
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Vladimira Boyadzhieva
Site Name
Medical Center Medconsult Pleven OOD
Contact Person Name
Krasimira Tsoneva
Contact Person Email
dr.krasimira.tsoneva@abv.b

Greece

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
252
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Asklepieion Voulas General Hospital
Department Name
Rheumatology
Contact Person Name
Antonia Elezoglou
Contact Person Email
taniaelezoglou@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Department of Pathophysiology
Contact Person Name
Andreas V. Goules
Contact Person Email
agoules@med.uoa.gr
Site Name
Laiko General Hospital Of Athens
Department Name
Departments of Physiology and Pathophysiology, Outpatient Rheumatology Clinic
Contact Person Name
Clio P. Mavragani
Contact Person Email
cliopmavragani@gmail.com
Site Name
Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name
Rheumatology
Contact Person Name
Andreas Bounas
Contact Person Email
andreasgbounas@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
274
Number Of Sites
14
Number Of Participants
18

Sites

Site Name
Pratia S.A.
Department Name
Pratia Poznań
Contact Person Name
Magdalena Szyszko
Contact Person Email
roza.jerzewska@pratia.com
Site Name
Lukmed 2 Sp. z o.o.
Department Name
ETG Siedlce
Contact Person Name
Tomasz Bocianowski
Contact Person Email
t.bocianowski@etg-network.com
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
CENTRUM MEDYCZNE REUMA PARK
Contact Person Name
Paula Sliwinska-Stanczyk
Contact Person Email
stanczyki@post.pl
Site Name
Etg Warszawa Sp. z o.o.
Contact Person Name
Malgorzata Socik-Pojawa
Contact Person Email
m.socikpojawa@etg-network.com
Site Name
Med Polonia Sp. z o.o.
Contact Person Name
Maria Jaraczewska-Baumann
Contact Person Email
medi-consult@wp.pl
Site Name
Reumed Sp. z o.o.
Department Name
Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
Contact Person Name
Mariusz Piotrowski
Contact Person Email
mariusz_piotrowski@yahoo.com
Site Name
Centrum Medyczne K2J2
Contact Person Name
Katarzyna Kaminska-Stachniak
Contact Person Email
j.topolska@k2j2.pl
Site Name
Gyncentrum Sp. z o.o.
Department Name
NZOZ Holsamed - Oddzial Libero
Contact Person Name
Wojciech Sydor
Contact Person Email
w.sydor@holsaclinical.com
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Pracownia Badan Klinicznych Salus
Contact Person Name
Katarzyna Rachwal-Siek
Contact Person Email
magdalena.golabek@pbks.com.pl
Site Name
Twoja Przychodnia PCM
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
bednarek@twojaprzychodnia.com
Site Name
Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł Hrycaj
Contact Person Name
Paweł Hrycaj
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Marzena Olesinska
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa

Sponsor

Primary sponsor

Full Name
Otsuka Pharmaceutical Development & Commercialization Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
codes:1,13,15 (DSMB coordination),5,8
Name
PPD Global Ltd.
Responsibilities
code:1
Name
PPD International Holdings LLC
Responsibilities
code:4
Name
PPD Romania S.R.L.
Responsibilities
code:1
Name
Syneos Health Netherlands B.V.
Responsibilities
code:4

Third parties

  • {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Expense Reimbursement Management","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"World Courier (U.K.) Limited","duties_or_roles":"Courier","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA; code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,13,15 (DSMB coordination),5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Simulations Plus Inc.","duties_or_roles":"Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Verily Life Sciences LLC","duties_or_roles":"Digital biomarker devices","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Rti Health Solutions","duties_or_roles":"Qualitative in-trial interviews","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Sjoegren'S Foundation Inc.","duties_or_roles":"Training","organisation_type":"Patient organisation/association"}
  • {"country":"United Kingdom","full_name":"Medicys Limited","duties_or_roles":"Qualitative in-trial interviews (Exafield works for Medicys)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Romania","full_name":"PPD Romania S.R.L.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Bioanalytical Testing Lab","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Sibeprenlimab
Active Substance
SIBEPRENLIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
EU product record present (euMpNumber PRD9497645, prodAuthStatus 1)
Maximum Dose
400 mg/day (max total 5600 mg)
Investigational Product Name
Sibeprenlimab placebo
Modality
Other

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