A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Viti-Up
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
2 other identifiers
interventional
614
19 countries
148
Brief Summary
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed. Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3. In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2023
Typical duration for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
December 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
ExpectedNovember 10, 2025
November 1, 2025
1.8 years
November 1, 2023
November 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.
Week 48
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.
Week 48
Secondary Outcomes (10)
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
Week 48
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
Week 24
Percent Change from Baseline in F-VASI
Week 24
Percent Change From Baseline in T-VASI
Week 48
Percentage of Participants Achieving F-VASI 90 (≥ 90% Improvement in F-VASI From Baseline)
Week 48
- +5 more secondary outcomes
Study Arms (10)
Study 1, Period A: Group 1
EXPERIMENTALParticipants will receive upadacitinib 15 mg once daily for 48 weeks.
Study 1, Period A: Group 2
PLACEBO COMPARATORParticipants will receive placebo once daily for 48 weeks.
Study 2, Period A: Group 1
EXPERIMENTALParticipants will receive upadacitinib 15 mg once daily for 48 weeks.
Study 2, Period A: Group 2
PLACEBO COMPARATORParticipants will receive placebo once daily for 48 weeks.
Study 1, Period B: Group 1 Open-Label Extension Period
EXPERIMENTALParticipants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.
Study 1, Period B: Group 2 Open-Label Extension Period
EXPERIMENTALParticipants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
Study 2, Period B: Group 1 Open-Label Extension Period
EXPERIMENTALParticipants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.
Study 2, Period B: Group 2 Open-Label Extension Period
EXPERIMENTALParticipants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
(Optional) Study 3, Period B: Open Label Upadacitinib
EXPERIMENTALOpen Label Upadacitinib Participants will receive upadacitinib 15 mg once daily for 112 weeks
(Optional) Study 3:
EXPERIMENTALParticipants will receive 15 mg upadacitinib once daily for 112 weeks and NB-UVB for up to 28 weeks
Interventions
Oral Tablets
NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week
Eligibility Criteria
You may qualify if:
- Documented clinical diagnosis of non-segmented vitiligo (NSV).
- At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:
- \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
- \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have a sign of actively progressing vitiligo; or
- \>= 0.5 F-VASI and 10 \<= T-VASI \< 50.
You may not qualify if:
- Segmental or localized vitiligo.
- History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
- \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (148)
Advanced Research Associates - Glendale /ID# 259915
Glendale, Arizona, 85308, United States
Alliance Dermatology and Mohs Center /ID# 259926
Phoenix, Arizona, 85032, United States
Private Practice - Dr. Tooraj Raoof /ID# 260055
Encino, California, 91436, United States
University of California Irvine /ID# 260080
Irvine, California, 92697-1385, United States
Vitiligo & Pigmentation Institute of Southern California /ID# 259970
Los Angeles, California, 90036-5679, United States
Dermatology Research Associates /ID# 260056
Los Angeles, California, 90045, United States
Duplicate_Stanford University /ID# 260081
Redwood City, California, 94063, United States
Integrative Skin Science and Research /ID# 260060
Sacramento, California, 95815, United States
University of California Davis Health /ID# 260062
Sacramento, California, 95817, United States
Clinical Trials Research Institute /ID# 259910
Thousand Oaks, California, 91320-2130, United States
Skin Care Research Boca Raton /ID# 260094
Boca Raton, Florida, 33486-2269, United States
Apex Clinical Trials /ID# 260096
Brandon, Florida, 33511, United States
Florida Academic Dermatology Center /ID# 259919
Coral Gables, Florida, 33134-5755, United States
Direct Helpers Research Center /ID# 259932
Hialeah, Florida, 33012, United States
Skin Care Research - Hollywood /ID# 260101
Hollywood, Florida, 33021-6748, United States
Encore Medical Research /ID# 259963
Hollywood, Florida, 33021, United States
GSI Clinical Research, LLC /ID# 259918
Margate, Florida, 33063, United States
Life Clinical Trials /ID# 260097
Margate, Florida, 33063, United States
Savin Medical Group, LLC /ID# 259968
Miami Lakes, Florida, 33014, United States
Advanced Clinical Research Institute /ID# 260058
Tampa, Florida, 33607, United States
Encore Medical Research - Weston /ID# 260542
Weston, Florida, 33331, United States
Cleaver Medical Group Dermatology /ID# 259925
Dawsonville, Georgia, 30534, United States
DeNova Research /ID# 260611
Chicago, Illinois, 60610, United States
Indiana University Health University Hospital /ID# 259974
Indianapolis, Indiana, 46202, United States
Dawes Fretzin, LLC /ID# 260068
Indianapolis, Indiana, 46256, United States
Tufts Medical Center /ID# 260088
Boston, Massachusetts, 02111-1552, United States
UMass Memorial Medical Center /ID# 259921
Worcester, Massachusetts, 01605, United States
Oakland Hills Dermatology /ID# 260602
Auburn Hills, Michigan, 48326, United States
Great Lakes Research Group - Bay City /ID# 260600
Bay City, Michigan, 48706, United States
Hamzavi Dermatology - Canton /ID# 260545
Canton, Michigan, 48187, United States
Clarkston Dermatology /ID# 260069
Clarkston, Michigan, 48346, United States
Henry Ford Medical Center - New Center One /ID# 260059
Detroit, Michigan, 48202-3046, United States
Minnesota Clinical Study Center /ID# 260154
New Brighton, Minnesota, 55112, United States
Vivida Dermatology- Flamingo /ID# 260609
Las Vegas, Nevada, 89119-5190, United States
Schweiger Dermatology, P.C. /ID# 260152
New York, New York, 07044-2946, United States
Icahn School of Medicine at Mount Sinai /ID# 259909
New York, New York, 10029, United States
DermResearchCenter of New York, Inc. /ID# 259906
Stony Brook, New York, 11790, United States
ClinOhio Research Services /ID# 260300
Columbus, Ohio, 43213-4440, United States
Oregon Medical Research Center /ID# 259911
Portland, Oregon, 97201, United States
Oregon Dermatology and Research Center /ID# 259917
Portland, Oregon, 97210, United States
Medical University of South Carolina /ID# 259916
Charleston, South Carolina, 29425, United States
Bellaire Dermatology Associates /ID# 260044
Bellaire, Texas, 77401, United States
Dermatology Treatment and Research Center /ID# 260078
Dallas, Texas, 75230, United States
Innovative Dermatology - Plano /ID# 260628
Plano, Texas, 75024, United States
Dermatology Clinical Research Center of San Antonio /ID# 260047
San Antonio, Texas, 78229, United States
Progressive Clinical Research /ID# 260070
San Antonio, Texas, 78229, United States
Buenos Aires Skin /ID# 259885
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055, Argentina
Instituto de Neumonologia y Dermatologia /ID# 259888
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Psoriahue Med Interdisciplinar /ID# 259890
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Instituto De Investigaciones Clínicas Córdoba /ID# 260371
Córdoba, Córdoba Province, 5000, Argentina
Sanatorio 9 de Julio /ID# 260245
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 259889
Buenos Aires, 1061, Argentina
Cliniques Universitaires UCL Saint-Luc /ID# 259429
Brussels, Brussels Capital, 1200, Belgium
Grand Hôpital de Charleroi - Les Viviers /ID# 259437
Charleroi, Hainaut, 6280, Belgium
UZ Gent /ID# 259430
Ghent, Oost-Vlaanderen, 9000, Belgium
CHU de Liege /ID# 259427
Liège, 4000, Belgium
Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 259955
Sofiya, Sofia, 1407, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 259956
Sofiya, Sofia, 1463, Bulgaria
Diagnosis - Consult Centre 20 - Sofia /ID# 259953
Sofiya, Sofia, 1618, Bulgaria
Medical Center Cordis /ID# 259954
Pleven, 5800, Bulgaria
Dermatology Research Institute - Blackfoot Trail /ID# 261175
Calgary, Alberta, T2J 7E1, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 260239
Surrey, British Columbia, V3R 6A7, Canada
Wiseman Dermatology Research /ID# 260236
Winnipeg, Manitoba, R3M 3Z4, Canada
Brunswick Dermatology Center /ID# 260237
Fredericton, New Brunswick, R3M 3Z4, Canada
LEADER Research /ID# 260407
Hamilton, Ontario, L8L 3C3, Canada
Private Practice - Dr. Kim Papp Clinical Research /ID# 260406
Waterloo, Ontario, N2J 1C4, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 260241
Québec, Quebec, G1V 4X7, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 260238
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 260919
Beijing, Beijing Municipality, 100730, China
Dermatology Hospital of Southern Medical University /ID# 260136
Guangzhou, Guangdong, 510091, China
The Second Affiliated Hospital of Guangzhou Medical University /ID# 259929
Guangzhou, Guangdong, 510260, China
Renmin Hospital of Wuhan University /ID# 260477
Wuhan, Hubei, 430060, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 260011
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 260340
Xi'an, Shaanxi, 710061, China
Shandong Dermatological Hospital /ID# 260338
Jinan, Shandong, 250022, China
Huashan Hospital, Fudan University /ID# 259823
Shanghai, Shanghai Municipality, 200040, China
Chengdu Second Municipal People's Hospital /ID# 260423
Chengdu, Sichuan, 610017, China
West China Hospital, Sichuan University /ID# 260624
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital /ID# 259812
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University /ID# 260017
Kunming, Yunnan, 650032, China
Hangzhou Third People'S Hospital /ID# 261005
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260626
Hangzhou, Zhejiang, 310020, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 259822
Wenzhou, Zhejiang, 325000, China
Chu de Nice-Hopital L'Archet Ii /Id# 259442
Nice, Alpes-Maritimes, 06202, France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 259443
Bordeaux, Gironde, 33000, France
CHU Toulouse - Hopital Larrey /ID# 259445
Toulouse, Haute-Garonne, 31400, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259446
Créteil, Paris, 94010, France
HCL - Hopital Edouard Herriot /ID# 259444
Lyon, Rhone, 69003, France
Universitaetsklinikum Erlangen /ID# 260153
Erlangen, Bavaria, 91054, Germany
Klinikum rechts der Isar /ID# 260291
Munich, Bavaria, 81675, Germany
Dermatologie Mahlow /ID# 260148
Blankenfelde-Mahlow, Brandenburg, 15831, Germany
MVZ Dermatologisches Zentrum Bonn GmbH /ID# 260287
Bonn, Hesse, 53111, Germany
Universitaetsklinikum Frankfurt /ID# 260288
Frankfurt am Main, Hesse, 60590, Germany
Fachklinik Bad Bentheim /ID# 260293
Bad Bentheim, Lower Saxony, 48455, Germany
Universitaetsklinikum Muenster /ID# 260147
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsmedizin Mainz /ID# 260151
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 260289
Dresden, Saxony, 01307, Germany
Private Practice - Dr. Abdou Zarzour /ID# 260290
Halle, Saxony-Anhalt, 06108, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 260294
Berlin, 10117, Germany
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 260072
Debrecen, 4031, Hungary
Hadassah Medical Center-Hebrew University /ID# 259849
Jerusalem, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center /ID# 259851
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 259850
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 259852
Haifa, 3109601, Israel
Rabin Medical Center /ID# 260420
Petah Tikva, 4941492, Israel
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 259771
Rome, Roma, 00144, Italy
ASST degli Spedali Civili di Brescia /ID# 259772
Brescia, 25123, Italy
Nagoya City University Hospital /ID# 260551
Nagoya, Aichi-ken, 467-8602, Japan
Dermatology and Ophthalmology Kume Clinic /ID# 260555
Sakai-shi, Osaka, 593-8324, Japan
The University of Osaka Hospital /ID# 261285
Suita-shi, Osaka, 565-0871, Japan
Nippon Medical School Hospital /ID# 260550
Bunkyo-ku, Tokyo, 113-8603, Japan
Tokyo Medical University Hospital /ID# 260552
Shinjuku-ku, Tokyo, 160-0023, Japan
Yamagata University Hospital /ID# 260553
Yamagata, Yamagata, 990-9585, Japan
Yamanashi Prefectural Central Hospital /ID# 260554
Kofu, Yamanashi, 400-8506, Japan
Bravis Ziekenhuis /ID# 259501
Bergen op Zoom, North Brabant, 4624 VT, Netherlands
Amphia Ziekenhuis /ID# 259696
Breda, North Brabant, 4818 CK, Netherlands
Amsterdam UMC, locatie AMC /ID# 259676
Amsterdam, North Holland, 1105 AZ, Netherlands
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 259690
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 260016
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Malopolskie Centrum Kliniczne /ID# 259686
Krakow, Lesser Poland Voivodeship, 30-149, Poland
Krakowskie Centrum Medyczne /ID# 261424
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Klinika Osipowicz & Turkowski sp.z.o.o /ID# 259761
Warsaw, Masovian Voivodeship, 00-716, Poland
Klinika Ambroziak Dermatologia /ID# 260018
Warsaw, Masovian Voivodeship, 02-953, Poland
Royalderm Agnieszka Nawrocka /ID# 259691
Warsaw, Masovian Voivodeship, 02-962, Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 259753
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Medyczne Angelius Provita /ID# 259752
Katowice, Silesian Voivodeship, 40-615, Poland
Twoja Przychodnia SCM /ID# 259757
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Unidade Local de Saude de Coimbra, EPE /ID# 259793
Coimbra, 3000-075, Portugal
Unidade Local de Saude da Regiao de Leiria, EPE /ID# 259789
Leiria, 2410-197, Portugal
Hospital CUF Descobertas /ID# 259788
Lisbon, 1998-018, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 259791
Porto, 4099-003, Portugal
Santa Cruz Behavioral (SCB) Research Center /ID# 260100
Bayamón, 00961-6910, Puerto Rico
Dr. Samuel Sanchez PSC /ID# 260090
Caguas, 00727, Puerto Rico
Mindful Medical Research /ID# 260092
San Juan, 00918-3756, Puerto Rico
Derma therapy spol /ID# 260838
Bratislava, Bratislava Region, 851 01, Slovakia
Fakultna nemocnica Trnava /ID# 260164
Trnava, 917 02, Slovakia
Chungnam National University Hospital /ID# 260917
Daejeon, Daejeon Gwang Yeogsi, 35015, South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 260836
Bucheon-si, Gyeonggido, 14584, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 260880
Suwon, Gyeonggido, 16247, South Korea
Ajou University Hospital /ID# 260916
Suwon, Gyeonggido, 16499, South Korea
Kyung Hee University Hospital at Gangdong /ID# 260879
Seoul, Seoul Teugbyeolsi, 05278, South Korea
Hospital Universitario Germans Trias i Pujol /ID# 259371
Badalona, Barcelona, 08916, Spain
Hospital Universitario de Getafe /ID# 259376
Getafe, Madrid, 28905, Spain
Hospital Universitario Quironsalud Madrid /ID# 259377
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Clinico San Cecilio /ID# 259374
Granada, 18016, Spain
Grupo Pedro Jaen /ID# 259375
Madrid, 28006, Spain
Consorci Hospital General Universitario de Valencia /ID# 259372
Valencia, 46014, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 259373
Zaragoza, 50009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2023
First Posted
November 7, 2023
Study Start
December 19, 2023
Primary Completion
September 23, 2025
Study Completion (Estimated)
February 1, 2028
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.