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ENROLLING BY INVITATION

NCT05248659

PHASE2/PHASE3

Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN

Official title: A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2022-04-05

Completion Date

2029-12-31

Last Updated

2026-05-05

Healthy Volunteers

Conditions

Immunoglobulin A Nephropathy

Interventions

DRUG

Sibeprenlimab 400 mg s.c. Q4weeks

Sibeprenlimab 400 mg s.c. q 4 weeks

Inclusion Criteria: * Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN. * 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. Exclusion Criteria: * Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201. * Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement. * Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility. * Subjects who have a positive pregnancy test result prior to receiving IMP. * Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter. * Biological male subjects who do not agree to avoid donation of sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter. * Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein \> 3.5 g with concurrent hypoalbuminemia (serum albumin \< 2.5 g/dL), hyperlipidemia (total cholesterol \> 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (\> 3.5 g/day) will be eligible. * Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary. * 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. * Subject has a body mass index \< 16 kg/m\^2. * Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation). * Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppressive therapy (ie, steroids such as targeted release budesonide, complement inhibitors, mycophenolate, rituximab). Note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids (\<= 14 days) are allowed.

Locations (158)

Clinical Research Site #336

Birmingham, Alabama, United States

Clinical Research Site #325

Los Angeles, California, United States

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Palo Alto, California, United States

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Denver, Colorado, United States

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Lauderdale Lakes, Florida, United States

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Atlanta, Georgia, United States

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Lawrenceville, Georgia, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

Clinical Research Site #320

Shelby, Michigan, United States

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Great Neck, New York, United States

Clinical Research Site #350

Columbus, Ohio, United States

Clinical Research Site #374

Dakota Dunes, South Dakota, United States

Clinical Research Site #324

Houston, Texas, United States

Clinical Research Site #361

Milwaukee, Wisconsin, United States

Clinical Research Site #800

Buenos Aires, Argentina

Clinical Research Site #802

Buenos Aires, Argentina

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Córdoba, Argentina

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Garran, Australian Capital Territory, Australia

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Concord, New South Wales, Australia

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Kogarah, New South Wales, Australia

Clinical Research Site

New Lambton Heights, New South Wales, Australia

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Saint Leonards, New South Wales, Australia

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Adelaide, South Australia, Australia

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Fitzroy, Victoria, Australia

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St Albans, Victoria, Australia

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Liverpool, Australia

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Genk, Belgium

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Genk, Belgium

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Recife, Pernambuco, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Joinville, Santa Catarina, Brazil

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São José do Rio Preto, So Paulo, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Scarborough Village, Ontario, Canada

CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

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Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Guangzhou, Guangdong, China

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Changsha, Hunan, China

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Wuxi, Jiangsu, China

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Nanchang, Jiangxi, China

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Jinan, Shandong, China

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Chengdu, Sichuan, China

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Yibin, Sichuan, China

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Split, Croatia

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Zagreb, Croatia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

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Grenoble, Auvergne-Rhône-Alpes, France

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Nîmes, Gard, France

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Nantes, Loire-Atlantique, France

Clinical Research Site #439

Limoges, New Aquitaine, France

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Sr Priest En Jarez, Pays de la Loire Region, France

Clinical Research Site #455

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

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Heraklion, Greece

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Hong Kong, New Territories, Hong Kong

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Hong Kong, Hong Kong

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Shatin, Hong Kong

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Pécs, Baranya, Hungary

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Hyderabad, Deccan, India

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Ahmedabad, Gujarat, India

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Nadiād, Gujarat, India

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Bengaluru, Karnataka, India

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Manipal, Karnataka, India

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Kozhikode, Kerala, India

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Thiruvananthapuram, Kerala, India

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Pune, Maharashtra, India

Clinical Research Site #075

New Delhi, National Capital Territory of Delhi, India

Clinical Research Site #077

Chandigarh, Punjab, India

Clinical Research Site #080

Rajipet, Tamil Nadu, India

Clinical Research Site #078

Afzalganj, Telangana, India

Clinical Research Site #076

Lucknow, Uttar Pradesh, India

Clinical Research Site #494

Ashkelon, Israel

Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)

Kfar Saba, Israel

Clinical Research Site #495

Nahariya, Israel

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Petach Tiqwa, Israel

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Bologna, Italy

Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino

Genova, Italy

Clinical Research Site #509

Pavia, Italy

Clinical Research Site #507

Piacenza, Italy

Clinical Research Site #705

Nagoya, Aichi-ken, Japan

Clinical Research Site #709

Toyoake-shi, Aichi-ken, Japan

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Chiba, Chiba, Japan

Clinical Research Site #707

Urayasu-shi, Chiba, Japan

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Kobe, Hyōgo, Japan

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Tsukuba, Ibaraki, Japan

Clinical Research Site #714

Kawasaki-shi, Kanagawa, Japan

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Kashihara, Nara, Japan

Clinical Research Site #717

Yufu, Oita Prefecture, Japan

Clinical Research Site #715

Bunkyo, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Fukuoka, Japan

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Minatoku, Japan

Clinical Research Site #716

Miyazaki, Japan

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Tochigi, Japan

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Ipoh, Perak, Malaysia

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Petaling Jaya, Selangor, Malaysia

Clinical Research Site #123

Kuala Lumpur, Malaysia

Clinical Research Site #125

Kuala Lumpur, Malaysia

Clinical Research Site #121

Kuala Lumpur, Malaysia

Clinical Research Site #120

Kuantan, Malaysia

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Clinical Research Site #132

Quezon City, Philippines

Clinical Research Site #131

Quezon City, Philippines

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Krakow, Poland

Clinical Research Site #530

Lodz, Łódź Voivodeship, Poland

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Braga, Portugal

Clinical Research Site #545

Carnaxide, Portugal

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Porto, Portugal

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Porto, Portugal

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Busan, Busan Gwang'yeogsi, South Korea

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Daegu, Daegu Gwang'yeogsi, South Korea

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Gwangju, Gwangju Gwang'yeogsi, South Korea

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Seoul, Seoul Teugbyeolsi, South Korea

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Seoul, Seoul Teugbyeolsi, South Korea

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Anyang, South Korea

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Hwaseong-si, South Korea

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Seongnam, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Córdoba, Spain

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Ellenboro, Spain

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Madrid, Spain

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Madrid, Spain

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Seville, Spain

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Seville, Spain

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Colombo, Sri Lanka

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Kandy, Sri Lanka

Clinical Research Site #154

Kurunegala, Sri Lanka

Clinical Research Site #150

Nugegoda, Sri Lanka

Clinical Research Site #161

Kaohsiung City, Taiwan

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Keelung, Taiwan

Clinical Research Site #163

New Taipei City, Taiwan

Clinical Research Site #164

Taipei, Taiwan

Clinical Research Site #165

Taipei, Taiwan

Clinical Research Site #170

Bangkok, Thailand

Clinical Research Site #175

Bangkok, Thailand

Clinical Research Site #172

Chiang Mai, Thailand

Clinical Research Site #171

Din Daeng, Thailand

Clinical Research Site #173

Khon Kaen, Thailand

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Leicester, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Hanoi, Vietnam

Clinical Research Directory

Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (158)