Dravet Syndrome (DS)Phase 3NCT05163314
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
A Phase 3 study testing Soticlestat in people with Dravet Syndrome (DS) and Lennox Gastaut Syndrome (LGS), run by Takeda at 116 sites in 20 countries.
Trial summary
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. Read more about this study
- Who is it for?
- Ages 2 to 56 years
- Conditions the study is for
- Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
- What is being tested?
- Soticlestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 116 sitesin 20 countries
- Study dates
- 4 Mar 2022to 24 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Participant must have:
- Been previously enrolled in a phase 3 soticlestat clinical study.
Who cannot join
- Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
- Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
- Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.
Trial locations and contacts
116 sites in 20 countries.
116 sites in 20 countries
United States26 sites
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, 29425
Colorado Children's Hospital
Denver, Colorado, 80218
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, 76104
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, 52242
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, 07039
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Sunrise Pediatric Neurology
Marietta, Georgia, 30066
Boston Children's Health Physicians (BCHP)
New York, New York, 10003
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, 10016
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Oregon Health and Science University
Portland, Oregon, 97239
Minnesota Epilepsy Group PA
Saint Paul, Minnesota, 55102
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah, 84113
University of California Benioff Children's Hospital
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98105
MultiCare Institute for Research & Innovation (Tacoma)
Tacoma, Washington, 98402
University of Toledo
Toledo, Ohio, 43614
Center For Neurosciences
Tucson, Arizona, 85718
Pediatric Neurology PA
Winter Park, Florida, 32789
WellSpan Oncology Research
York, Pennsylvania, 17403
Japan13 sites
Hokkaido University Hospital
Chuo-Ku, Tokyo, 104-0045
Fukuoka Children's Hospital
Fukuoka, Hukuoka, 813-0017
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, 187-0031
Kumamoto-Ezuko Medical Center for The Severely Disabled
Kumamoto, Kumamoto, 862-0947
Aichi Medical University Hospital
Nagakute-Shi, Aiti, 480-1195
Yasuhara Childrens Clinic
Neyagawa, Osaka, 572-0085
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, 950-2074
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
National Hospital Organization Nagasaki Medical Center
Omura-Shi, Nagasaki, 856-0835
Osaka City General Hospital
Osaka, Osaka, 534-0021
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-0953
Osaka University Hospital
Suita-Shi, Osaka, 565-0871
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama, Kanagawa, 232-0066
China12 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, 100045
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
The Second Affiliated Hospital of Guangzhou Medical Univeristy
Guangzhou, Guangdong, 510260
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, 510623
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518026
Wuhan Childrens hospital
Wuhan, Hubei, 430010
Italy6 sites
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, 50139
ASST di Mantova - Azienda Ospedaliera Carlo Poma
Mantua, Lombardy, 46100
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, 27100
Ospedale Bellaria
Rome, Lazio, 00185
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
Rome, Lazio, 00197
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio
Spain6 sites
Hospital Regional Universitario de Malaga Hospital General
Almería, 04009
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
Hospital Vithas La Salud
Granada, 18008
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Centro de Neurologia Avanzada
Seville, 41013
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Brazil5 sites
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-887
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, 81210-310
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000
Universidade Federal de Sao Paulo
São Paulo, 04023-900
Universidade de Sao Paulo
São Paulo, 05403-010
France5 sites
CHRU Dijon Hopital General
Dijon, Cote-d'Or, 21079
Hopital Roger Salengro
Lille, Nord, 59000
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, 13005
Hopital Necker - Enfants Malades
Paris, 75015
Hopital Robert Debre
Paris, 75019
Russia5 sites
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk, 660022
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, Moscow, 117437
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, 125412
Tyumen State Medical Academy
Tyumen, 625023
UGMK-Zdorojie, LLC
Yekaterinburg, 620144
Ukraine5 sites
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
Dnipro, Dnipropetrovsk Oblast, 49100
Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
Dnipro, Dnipropetrovsk Oblast, 49101
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
Ivano-Frankivsk, 76018
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
Kyiv, 4080
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Kyiv, 4209
Australia4 sites
Queensland Childrens Hospital
Brisbane, Queensland, 4101
Austin Hospital
Heidelberg, Victoria, 3084
Alfred Hospital
Melbourne, Victoria, 3004
Sydney Children's Hospital
Randwick, New South Wales, 2031
Germany4 sites
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, North Rhine-Westphalia, 33617
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, 60528
Alberta Childrens Hospital
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
Radeberg, Saxony, 01454
Greece4 sites
Childrens' Hospital of Athens 'P. and A. Kyriakou'
Athens, Attica, 115 27
Attikon University General Hospital
Chaïdári, Attica, 124 62
University General Hospital of Larissa
Larissa, 411 10
Hippokration Hospital
Thessaloniki, 546 42
Hungary4 sites
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, 1023
Bethesda Gyermekkorhaz
Budapest, 1143
Orszagos Klinikai Idegtudomanyi Intezet
Budapest, 1145
Pecsi Tudomanyegyetem
Pécs, Baranya, 7623
Poland4 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, Masovian Voivodeship, 02-091
Serbia4 sites
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, 11000
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, 11000
University Clinical Center Nis
Niš, 18 000
Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21 000
Belgium3 sites
Hopital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, 1020
UZ Antwerpen
Edegem, Antwerpen, 2650
Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340
Canada2 sites
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Child and Family Research Institute
Vancouver, British Columbia, V5Z 4H4
Netherlands2 sites
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE
Stichting Epilepsie Instellingen Nederland
Zwolle, Overijssel, 8025 BV
About this study
Official title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.
Read the detailed description
The drug being tested in this study is called soticlestat (TAK-935). Soticlestat administered long-term in pediatric and adult participants who participated in an antecedent soticlestat Phase 3 clinical study will be assessed for additional safety and tolerability data along with efficacy analysis, as well as palatability and acceptability of soticlestat in the pediatric population.
The study will enroll approximately 400 participants.
All participants will receive soticlestat based on their weight in the 2-week Titration Period (for participants who roll over from an antecedent double-blind study). Following the Titration Period, participants will continue to receive the same dose in the Maintenance Period. At the end of maintenance period, the dose will be down-tapered (unless already at the lowest dose) and then stopped. Participants not tolerating minimum dose of 100 mg twice a day (BID) will be discontinued from the study.
This multi-center trial will be conducted worldwide. The overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched. Participants who discontinue study drug treatment before the completion of the study, will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.
- Being tested
- Soticlestat
- Keywords
- Drug Therapy
- Medical subject headings
- Epilepsies, Myoclonic, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoticlestatDrug
Also called TAK-935
Soticlestat mini-tablets or tablets
| Study group | Role | What they receive |
|---|---|---|
| Soticlestat | Experimental | Participants with DS and LGS received:Participants weighing<45 kilograms(kg):Soticlestat,mini-tablets,titrated from lower dose level (60milligrams[mg]-140mg)to higher dose level(100mg-200mg) twice daily(BID),based on body weight,orally or via enteral feeding tubes including but not limited to nasogastric(NG) tube,gastrostomy tube(G-tube),MIC-KEY button,up to 2 weeks in Titration Period(TP).Participants continued to receive the dose they were on at end of TP,for approximately 4 years in Maintenance Period(MP).Dose was tapered down to lower dose(not less than lowest dose level based on weight) every 3 days until study drug was discontinued(up to 1 week) in Taper Period.Participants weighing≥45kg/adults:Soticlestat, mini-tablets/tablets with starting dose of 200mgBID followed by 300mgBID,up to 2 weeks in TP.Participants continued to receive 300mgBID for approximately 4years in MP.Dose was tapered down to 100mg every 3 days until study drug was discontinued(up to 1 week) in Taper Period. Receives: Drug: Soticlestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug. A TEAE was defined as any AE that started or increased in severity after the first dose of the study drug in this open label extension (OLE) study.
Measured: Up to end of study (approximately 3.6 years)
Number of Participants in Each Category of the Columbia-Suicide Severity Rating Scale (C-SSRS) Over Time
C-SSRS systematically tracks suicidal ideation and behavior. Responses to questions in the C-SSRS at baseline and each post-baseline time point were collected for participants ≥6 years of age. C-SSRS incidences were categorized as follows: No Suicidal Ideation or Suicidal Behavior or Non-suicidal Self-injurious Behavior (No SI or SB or NSSJB), Non-suicidal Self-injurious Behavior (NSSJB), Suicidal Ideation (SI), and Suicidal Behavior (SB). For each visit (V), the "Yes" answer to the question with the highest severity rank was used to determine the C-SSRS category of a participant. The category Missing indicates the number of participants for whom no data was collected at the particular time point. For each time point only categories with at least 1 participant are presented. BL denotes Baseline and W denotes Week for the reported categories.
Measured: At first visit post-baseline (Visit 1 [V1], Day 1 of the current study), Week 13 (V4), Week 26 (V5), Week 52 (V7), Week 78 (V9), Week104 (v11), Week 130 (V12) and Week 156 (V13)
Change From Baseline in Body Weight for All Age Groups
BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.
Measured: From Baseline to Week 104
Change From Baseline in Height for All Age Groups
BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.
Measured: Baseline to Week 104
Number of Participants in Each Tanner Stage for Children 6 to 17 Years of Age During the Study
Tanner assessment scores were used to document the stage of development of puberty by assessing the secondary sexual characteristics, rated in 5 stages: Stage 1 (no development) to 5 (adult-like development in quantity and size) by age (6 to 17 years of age) and sex (boys and girls) during the study. Tanner scale boy clinical classification test names for each stage are reported as follows: TANN02-Genitalia and TANN02-Pubic Hair. Tanner scale girl clinical classification test names for each stage are reported as follows: TANN01-Breast and TANN01-Pubic Hair.
Measured: From Baseline to Week 130
Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study
Absolute values of IGF1 were summarized descriptively as a continuous variable by age and by sex (male and female). If multiple assessments for a participant at different visits at a particular age were available, then the average of all data for that participant were used for the summary.
Measured: From Baseline to Week 130
Secondary outcomes (8)
Percent Change From Baseline in Total Seizure Frequency Per 28 Days
Seizure frequency per 28 days was defined as total number of seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of seizures per 28 days during Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Measured: From Baseline to Week 156
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in DS Cohort
Convulsive seizure frequency per 28 days was defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of convulsive seizures per 28 days during Treatment Period - frequency of convulsive seizures per 28 days at Baseline) divided by the frequency of convulsive seizures per 28 days at Baseline multiplied by 100.
Measured: From Baseline to Week 156
Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days in LGS Cohort
MMD seizure frequency per 28 days was defined as the total number of MMD seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from baseline was defined as (frequency of MMD seizures per 28 days during the Treatment Period - frequency of MMD seizures per 28 days at Baseline) divided by the frequency of MMD seizures per 28 days at Baseline multiplied by 100.
Measured: From Baseline to Week 144
Number of Participants With Improvement in the Clinical Global Impression of Improvement (CGI-I) Score
The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Reported here is the number of participants with improvement, which includes the CGI-I responses: very much improved, much improved, minimally improved.
Measured: From Baseline to Week 156
Number of Participants With Improvement in the Caregiver Global Impression of Improvement (Care GI-I) Score
The Care GI-I is a 7-point Likert scale that the caregiver used to rate a participant's change in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). The parent/caregiver completed the Care GI-I via interview. Reported here is the number of participants with improvement, which includes the Care GI-I responses: very much improved, much improved, minimally improved.
Measured: From Baseline to Week 156
Number of Participants With Improvement in the CGI-I Seizure Intensity and Duration Score
The CGI-I seizure intensity and duration instrument was used by the parent/caregiver to rate a participant's change in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms were rated on 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Reported here is the number of participants with improvement, which includes the CGI-I Seizure responses: very much improved, much improved, minimally improved.
Measured: From Baseline to Week 156
Number of Participants With Improvement in CGI-I Nonseizure Symptoms Score
The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator used to rate a participant's change in the caregiver-identified symptoms and impacts in select nonseizure domains since initiating the study drug. The participants were rated on 7-point scale by the investigator as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). At Baseline, a symptoms form was completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Reported here is the number of participants with improvement, which includes the CGI-I nonseizure symptoms responses: very much improved, much improved, minimally improved.
Measured: From Baseline to Week 156
Change From Baseline in Quality of Life Inventory-Disability (QI-Disability) Score
The QI-Disability tool is a parent/caregiver-reported questionnaire that evaluates quality of life in children with intellectual disabilities. It contains 32 items covering 6 domains of quality of life: physical health, positive emotions, negative emotions, social interaction, leisure and the outdoors, and independence. Items were rated on a 5-point Likert scale and then transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life. Negative change from baseline indicates worsening of quality of life.
Measured: From Baseline to Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start4 Mar 2022
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Why it stopped: Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-3003 study is no longer necessary. Therefore, Takeda has made a decision to close this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dravet Syndrome (DS)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163314
- Sponsor's protocol ID
- TAK-935-3003
- Other IDs
- 2021-002482-17, jRCT2051210182, 2022-502802-34-00
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2021
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.