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

April 29, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Clinical Research Site #800
      • Buenos Aires, Argentina, C1425
        • Clinical Research Site #802
      • Córdoba, Argentina, X5016LIG
        • Clinical Research Site #801
  • Australia
      • Liverpool, Australia, 2170
        • Clinical Research Site #011
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Clinical Research Site #003
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Clinical Research Site #013
      • Kogarah, New South Wales, Australia, 2217
        • Clinical Research Site #014
      • New Lambton Heights, New South Wales, Australia, 2305
        • Clinical Research Site
      • Saint Leonards, New South Wales, Australia, 2065
        • Clinical Research Site #006
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Research Site #012
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Clinical Research Site #001
      • St Albans, Victoria, Australia, 3021
        • Clinical Research Site #010
  • Belgium
      • Genk, Belgium, 3600
        • Clinical Research Site #401
      • Genk, Belgium, 3600
        • Clinical Research Site #405
  • Brazil
      • Rio de Janeiro, Brazil, 20550-010
        • Clinical Research Site #831
      • São Paulo, Brazil, 01246-903
        • Clinical Research Site #823
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Clinical Research Site #820
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Clinical Research Site #824
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89227-680
        • Clinical Research Site #821
    • So Paulo
      • São José do Rio Preto, So Paulo, Brazil, 15090-000
        • Clinical Research Site #822
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 0X7
        • Clinical Research Site #300
    • Ontario
      • Scarborough Village, Ontario, Canada, M1H 3G4
        • Clinical Research Site #305
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Clinical Research Site #036
      • Beijing, Beijing Municipality, China, 100034
        • Clinical Research Site #020
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Clinical Research Site #028
    • Hunan
      • Changsha, Hunan, China, 410011
        • Clinical Research Site #044
    • Jiangsu
      • Wuxi, Jiangsu, China, 214023
        • Clinical Research Site #030
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Clinical Research Site #022
    • Shandong
      • Jinan, Shandong, China, 250013
        • Clinical Research Site #026
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Clinical Research Site #038
      • Yibin, Sichuan, China, 644002
        • Clinical Research Site #025
  • Croatia
      • Split, Croatia, 21000
        • Clinical Research Site #413
      • Zagreb, Croatia, 10000
        • Clinical Research Site #414
  • Czechia
      • Prague, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze
  • France
    • Auvergne-Rhône-Alpes
      • Grenoble, Auvergne-Rhône-Alpes, France, 38043
        • Clinical Research Site #433
    • Gard
      • Nîmes, Gard, France, 30900
        • Clinical Research Site #430
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Clinical Research Site #432
    • New Aquitaine
      • Limoges, New Aquitaine, France, 87000
        • Clinical Research Site #439
    • Pays de la Loire Region
      • Sr Priest En Jarez, Pays de la Loire Region, France, 42270
        • Clinical Research Site #434
  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Clinical Research Site #455
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus
  • Greece
      • Heraklion, Greece, 71110
        • Clinical Research Site #472
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Clinical Research Site #060
      • Hong Kong, Hong Kong, 999077
        • Clinical Research Site #061
      • Kowloon, Hong Kong, 999077
        • Clinical Research Site #062
      • Shatin, Hong Kong, 999077
        • Clinical Research Site #063
    • New Territories
      • Hong Kong, New Territories, Hong Kong
        • Clinical Research Site #064
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Clinical Research Site #482
  • India
    • Deccan
      • Hyderabad, Deccan, India, 500082
        • Clinical Research Site #081
    • Gujarat
      • Ahmedabad, Gujarat, India, 382421
        • Clinical Research Site #073
      • Nadiād, Gujarat, India, 387001
        • Clinical Research Site #070
    • Karnataka
      • Bengaluru, Karnataka, India, 560099
        • Clinical Research Site #087
      • Manipal, Karnataka, India, 576104
        • Clinical Research Site #079
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Clinical Research Site #071
      • Thiruvananthapuram, Kerala, India, 695011
        • Clinical Research Site #074
    • Maharashtra
      • Pune, Maharashtra, India, 411057
        • Clinical Research Site #084
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 1100060
        • Clinical Research Site #075
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Clinical Research Site #077
    • Tamil Nadu
      • Rajipet, Tamil Nadu, India, 632517
        • Clinical Research Site #080
    • Telangana
      • Afzalganj, Telangana, India, 500012
        • Clinical Research Site #078
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Clinical Research Site #076
  • Israel
      • Ashkelon, Israel, 7830604
        • Clinical Research Site #494
      • Kfar Saba, Israel, 44281
        • Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)
      • Nahariya, Israel, 22100
        • Clinical Research Site #495
      • Petach Tiqwa, Israel, 49100
        • Clinical Research Site #493
  • Italy
      • Bologna, Italy, 40138
        • Clinical Research Site #512
      • Genova, Italy, 16132
        • Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino
      • Pavia, Italy, 27100
        • Clinical Research Site #509
      • Piacenza, Italy, 29121
        • Clinical Research Site #507
  • Japan
      • Fukuoka, Japan, 812-8582
        • Clinical Research Site #703
      • Minatoku, Japan, 105-8471
        • Clinical Research Site #712
      • Miyazaki, Japan, 889-1692
        • Clinical Research Site #716
      • Tochigi, Japan, 326-0843
        • Clinical Research Site #726
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Clinical Research Site #705
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Clinical Research Site #709
    • Chiba
      • Chiba, Chiba, Japan, 260-8712
        • Clinical Research Site #700
      • Urayasu-shi, Chiba, Japan, 279-002
        • Clinical Research Site #707
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Clinical Research Site #724
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Clinical Research Site #708
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 213-8587
        • Clinical Research Site #714
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Clinical Research Site #713
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan, 879-5593
        • Clinical Research Site #717
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Clinical Research Site #715
      • Nerima-ku, Tokyo, Japan, 177-8521
        • Clinical Research Site #727
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Clinical Research Site #123
      • Kuala Lumpur, Malaysia, 56000
        • Clinical Research Site #125
      • Kuala Lumpur, Malaysia, 59100
        • Clinical Research Site #121
      • Kuantan, Malaysia, 25100
        • Clinical Research Site #120
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Clinical Research Site #124
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47150
        • Clinical Research Site #126
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud Universitair Medisch Centrum
  • Philippines
      • Quezon City, Philippines, 1101
        • Clinical Research Site #132
      • Quezon City, Philippines, 1112
        • Clinical Research Site #131
  • Poland
      • Krakow, Poland, 31-513
        • Clinical Research Site #535
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 92-213
        • Clinical Research Site #530
  • Portugal
      • Braga, Portugal, 4710-243
        • Clinical Research Site #540
      • Carnaxide, Portugal, 2790-134
        • Clinical Research Site #545
      • Porto, Portugal, 4200-319
        • Clinical Research Site #544
      • Porto, Portugal, 4434-502
        • Clinical Research Site #543
  • Singapore
      • Singapore, Singapore, 119074
        • Clinical Research Site #142
      • Singapore, Singapore, 169608
        • Clinical Research Site #141
      • Singapore, Singapore, 308433
        • Clinical Research Site #140
  • South Korea
      • Anyang, South Korea, 14060
        • Clinical Research Site #104
      • Hwaseong-si, South Korea, 18450
        • Clinical Research Site #109
      • Seongnam, South Korea, 13620
        • Clinical Research Site #110
      • Seoul, South Korea, 134-727
        • Clinical Research Site #105
      • Seoul, South Korea, 3080
        • Clinical Research Site #107
      • Seoul, South Korea, 3722
        • Clinical Research Site #103
      • Seoul, South Korea, 5030
        • Clinical Research Site #108
      • Seoul, South Korea, 5355
        • Clinical Research Site #106
    • Busan Gwang'yeogsi
      • Busan, Busan Gwang'yeogsi, South Korea, 49241
        • Clinical Research Site #102
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, South Korea, 41944
        • Clinical Research Site #112
    • Gwangju Gwang'yeogsi
      • Gwangju, Gwangju Gwang'yeogsi, South Korea, 61469
        • Clinical Research Site #113
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 18450
        • Clinical Research Site #111
      • Seoul, Seoul Teugbyeolsi, South Korea, 6351
        • Clinical Research Site #100
  • Spain
      • Barcelona, Spain, 8025
        • Clinical Research Site #567
      • Barcelona, Spain, 8035
        • Clinical Research Site #566
      • Barcelona, Spain, 8907
        • Clinical Research Site #563
      • Córdoba, Spain, 14004
        • Clinical Research Site #565
      • Ellenboro, Spain, 28040
        • Clinical Research Site #564
      • Madrid, Spain, 28034
        • Clinical Research Site #573
      • Madrid, Spain, 28222
        • Clinical Research Site #570
      • Seville, Spain, 41009
        • Clinical Research Site #562
      • Seville, Spain, 41013
        • Clinical Research Site #561
  • Sri Lanka
      • Colombo, Sri Lanka, 8
        • Clinical Research Site #151
      • Kandy, Sri Lanka, 20000
        • Clinical Research Site #152
      • Kurunegala, Sri Lanka, 60000
        • Clinical Research Site #154
      • Nugegoda, Sri Lanka, 10250
        • Clinical Research Site #150
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Clinical Research Site #161
      • Keelung, Taiwan, 20104
        • Clinical Research Site #160
      • New Taipei City, Taiwan, 23561
        • Clinical Research Site #163
      • Taipei, Taiwan, 10002
        • Clinical Research Site #164
      • Taipei, Taiwan, 112202
        • Clinical Research Site #165
  • Thailand
      • Bangkok, Thailand, 10310
        • Clinical Research Site #170
      • Bangkok, Thailand, 1
        • Clinical Research Site #175
      • Chiang Mai, Thailand, 50200
        • Clinical Research Site #172
      • Din Daeng, Thailand, 10400
        • Clinical Research Site #171
      • Khon Kaen, Thailand, 40002
        • Clinical Research Site #173
  • United Kingdom
      • Leicester, United Kingdom, LE5 4PW
        • Clinical Research Site #581
      • London, United Kingdom, E1 1FR
        • Clinical Research Site #584
      • London, United Kingdom, SE 5 9RS
        • Clinical Research Site #582
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Clinical Research Site #336
    • California
      • Los Angeles, California, United States, 90027
        • Clinical Research Site #325
      • Palo Alto, California, United States, 94304
        • Clinical Research Site #370
    • Colorado
      • Denver, Colorado, United States, 80220
        • Clinical Research Site #330
    • Florida
      • Lauderdale Lakes, Florida, United States, 33313
        • Clinical Research Site #323
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Clinical Research Site #373
      • Lawrenceville, Georgia, United States, 30046
        • Clinical Research Site #356
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Research Site #369
      • Worcester, Massachusetts, United States, 01655
        • Clinical Research Site #331
    • Michigan
      • Shelby, Michigan, United States, 48315
        • Clinical Research Site #320
    • New York
      • Great Neck, New York, United States, 11021
        • Clinical Research Site #346
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Clinical Research Site #350
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57029
        • Clinical Research Site #374
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Research Site #324
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53213
        • Clinical Research Site #361
  • Vietnam
      • Hanoi, Vietnam
        • Clinical Research Site #181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks
Drug: Sibeprenlimab 400 mg s.c. Q4weeks
Sibeprenlimab 400 mg s.c. q 4 weeks
Other Names:
  • VIS649

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse Events
Time Frame: From baseline to the end-of-trial visit in Week 112.
From baseline to the end-of-trial visit in Week 112.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Over 12 and 24 months
Over 12 and 24 months
Urine protein/creatinine ratio (uPCR) in a 24-hour collection
Time Frame: At 12 and 24 months
At 12 and 24 months
Proportion of Subjects with Clinical Remission as defined in the protocol
Time Frame: At 12 and 24 months
At 12 and 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol
Time Frame: Over 24 months
Over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 417-201-00012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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