Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease (U-EMPOWER)

A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Upadacitinib

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Sydney Children's Hospital /ID# 262352
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Children's Hospital at Westmead /ID# 262350
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital /ID# 262351
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health - Monash Medical Centre - Clayton /ID# 262878
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Recruiting
      • Perth Children'S Hospital /ID# 272905
• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • Hospital Universite Enfants Reine Fabiola /ID# 261744
  • Liège, Belgium, 4000
    • Recruiting
    • CHR de la Citadelle /ID# 261749
  • Namur, Belgium, 5000
    • Recruiting
    • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Uza /Id# 261745
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires UCL Saint-Luc /ID# 261741
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitair Ziekenhuis Leuven /ID# 261740
• Brazil
  • São Paulo, Brazil, 01308-050
    • Recruiting
    • Hospital Sirio Libanes - Sao Paulo /ID# 262670
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36033-318
      • Recruiting
      • Galileo Medical Research Ltda /ID# 262602
  • Paraná
    • Curitiba, Paraná, Brazil, 80250-060
      • Recruiting
      • Hospital Pequeno Príncipe /ID# 262600
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Recruiting
      • Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 262601
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04543-011
      • Recruiting
      • Rocco & Nazato Servicos Medicos /ID# 262485
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • UMHAT Sveti Georgi /ID# 262590
  • Sofia, Bulgaria, 1606
    • Recruiting
    • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Recruiting
      • BC Children's Hospital /ID# 262237
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Center /ID# 262543
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine /ID# 262096
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Recruiting
      • Beijing Children's Hospital /ID# 262258
  • Guangdong
    • Guangzhou, Guangdong, China, 510620
      • Recruiting
      • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807
  • Henan
    • Zhengzhou, Henan, China, 450018
      • Recruiting
      • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300
  • Hunan
    • Changsha, Hunan, China, 410007
      • Recruiting
      • Hunan Children's Hospital /ID# 262512
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Jiangxi Provincial Children's Hospital /ID# 262295
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • Recruiting
      • Shengjing Hospital of China Medical University /ID# 262301
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200062
      • Recruiting
      • Children's Hospital of Shanghai /ID# 262356
    • Shanghai, Shanghai Municipality, China, 200065
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The Children's Hospital of Zhejiang University School of Medicine /ID# 262337
• France
  • Paris, France, 75019
    • Completed
    • Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308
  • Calvados
    • Caen, Calvados, France, 14033
      • Recruiting
      • CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311
  • Rhone
    • Bron, Rhone, France, 69500
      • Recruiting
      • Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 263422
• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • Recruiting
      • Agia Sofia Hospital /ID# 261792
    • Athens, Attica, Greece, 11527
      • Recruiting
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790
  • Crete
    • Heraklion, Crete, Greece, 71500
      • Recruiting
      • University General Hospital of Heraklion PA.G.N.I /ID# 261791
• Italy
  • Messina, Italy, 98125
    • Recruiting
    • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 275276
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Recruiting
      • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384
  • Roma
    • Rome, Roma, Italy, 00165
      • Recruiting
      • Ospedale Pediatrico Bambino Gesù /ID# 262379
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Recruiting
      • Tsujinaka Hospital - Kashiwanoha /ID# 262454
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital /ID# 262455
  • Miyagi
    • Sendai, Miyagi, Japan, 989-3126
      • Recruiting
      • Miyagi Children's Hospital /ID# 262459
  • Osaka
    • Izumi-Shi, Osaka, Japan, 594-1101
      • Recruiting
      • Osaka Women's and Children's Hospital /ID# 262549
  • Saga-ken
    • Saga, Saga-ken, Japan, 849-8501
      • Recruiting
      • Saga University Hospital /ID# 262753
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-8777
      • Recruiting
      • Saitama Children's Medical Center /ID# 262461
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Recruiting
      • Institute of Science Tokyo Hospital /ID# 262510
    • Fuchu-shi, Tokyo, Japan, 183-8561
      • Recruiting
      • Tokyo Metropolitan Children's Medical Center /ID# 262550
    • Setagaya City, Tokyo, Japan, 157-8535
      • Recruiting
      • National Center For Child Health And Development /ID# 262456
  • Toyama
    • Toyama, Toyama, Japan, 930-8550
      • Recruiting
      • Toyama Prefectural Central Hospital /ID# 262739
• New Zealand
  • Auckland, New Zealand, 0629
    • Completed
    • Starship Child Health /ID# 262576
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Recruiting
      • Christchurch Hospital. /ID# 262577
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • Recruiting
      • Gastromed Sp. z o.o /ID# 262367
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-730
      • Recruiting
      • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366
• Puerto Rico
  • Bayamón, Puerto Rico, 00960
    • Recruiting
    • Clinical Research Investigator Group /ID# 262357
  • Dorado, Puerto Rico, 00646
    • Recruiting
    • Puerto Rico Health Institute /ID# 262358
  • San Juan, Puerto Rico, 00909-1711
    • Recruiting
    • Clinical Research Puerto Rico /ID# 279595
• South Korea
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital /ID# 262324
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Yonsei University Health System Severance Hospital /ID# 262721
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center /ID# 262323
• Spain
  • Málaga, Spain, 29011
    • Recruiting
    • Hospital Regional Universitario de Malaga /ID# 262228
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio /ID# 262712
  • Zaragoza, Spain, 50009
    • Completed
    • Hospital Clinico Universitario Lozano Blesa /ID# 262227
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Recruiting
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Deu /ID# 262599
• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital /ID# 261695
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital /ID# 261696
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4TJ
    • Recruiting
    • Royal Hospital for Children and Young People /ID# 262388
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Recruiting
      • Addenbrookes Hospital /ID# 262707
  • England
    • Sheffield, England, United Kingdom, S10 2TH
      • Recruiting
      • Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
  • Greater London
    • London, Greater London, United Kingdom, E1 2ES
      • Recruiting
      • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Recruiting
      • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
• United States
  • California
    • Oakland, California, United States, 94609
      • Recruiting
      • UCSF Benioff Children's Hospital - Oakland /ID# 262217
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucile Packard Children's Hospital /ID# 262193
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado - Aurora /ID# 262207
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Connecticut Children's Medical Center - Hartford /ID# 262256
  • Illinois
    • Peoria, Illinois, United States, 61637-0001
      • Recruiting
      • OSF St. Francis Medical Center /ID# 262192
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health Riley Hospital for Children /ID# 262215
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital /ID# 262191
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413-2195
      • Recruiting
      • MNGI Digestive Health, P. A. /ID# 262204
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai /ID# 262216
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Recruiting
      • Univ NC Chapel Hill /ID# 262198
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • UH Cleveland Medical Center /ID# 262188
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Recruiting
      • Children's Hospital of Philadelphia - Main /ID# 262197

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Weight at Screening and Baseline must be >= 10 kg
• Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >= 6 (or SES-CD of >=4 for isolated ileal disease) excluding the presence of narrowing component.
• Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available
• Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor).

Exclusion Criteria:

• History of:

  • A diagnosis of CD prior to 2 years of age.

  • Currently known complications of CD such as:

    • Active abscess (abdominal or perianal);
    • Symptomatic bowel strictures;
    • More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
    • Ostomy or ileoanal pouch;
    • Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.
• Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)

• History of any of the following:

  • Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD);
  • Fulminant colitis or toxic megacolon;
  • Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels);
• Current diagnosis of any primary immune deficiency
• Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1: Open Label Induction Phase (Dose A); All participants in the open label induction phase of Period 1 will receive upadacitinib Dose A for 12 weeks based on body weight.	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ
Experimental: Period 1: Double-Blind Maintenance Phase (Dose B); Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive Dose B or C for 52 weeks (oral solution dose will be based on body weight)	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ
Experimental: Period 1: Double-Blind Maintenance Phase (Dose C); Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose C or B for 52 weeks (oral solution dose will be based on body weight)	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ
Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 1; Participants receiving double-blind maintenance therapy with upadacitinib Dose B or upadacitinib Dose C daily in Period 1 who complete the Week 64 visit will receive upadacitinib Dose B daily for up to 156 weeks.	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ
Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 2; Participants who were receiving rescue therapy with open-label upadacitinib Dose C during maintenance phase in Period 1 and completed the Week 64 visit will continue to receive upadacitinib Dose C daily for up to 156 weeks.	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ
Experimental: Period 2: Open Label Long-Term Extension Phase Cohort 3; Participants who did not achieve clinical response per PCDAI at Week 12 of Period 1 will receive an extended treatment with open-label upadacitinib Dose C daily for an additional 12 weeks. If they are responders after 12 weeks extended treatment, they will continue, otherwise they may be discontinued at the discretion of the investigator	Drug: Upadacitinib; Oral Solution/ Extended-Release Tablets; Other Names: RINVOQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64	PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.	At Week 64
Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.	Endoscopic response is defined as > 50% reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) score from Baseline (or for participants with a Baseline SES-CD of 4, at least a 2-point reduction from Baseline), as scored by a central reader.	At Week 64
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.	Through Week 156

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of clinical remission per PCDAI	Clinical remission per PCDAI is defined as PCDAI ≤ 10.	Week 12
Achievement of endoscopic response	Endoscopic response is defined as > 50% reduction in SES-CD score from Baseline (or for participants with a Baseline SES-CD of 4, at least a 2-point reduction from Baseline), as scored by a central reader.	Week 12
Achievement of endoscopic remission	Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no subscore > 1, as scored by a central reader	Week 12
Achievement of clinical response per PCDAI	Clinical response is defined as reduction in PCDAI of ≥ 15 points from Baseline	Week 12
Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12		Week 64
Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12	Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no subscore > 1, as scored by a central reader	Week 64
Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12	CS-free clinical remission per PCDAI: clinical remission per PCDAI and not receiving corticosteroids at Week 12 (for Period 1 induction endpoint[s]); or for at least 90 days prior to the study visit at which endpoint is assessed (for Period 1 maintenance endpoint[s] and Period 2 endpoint[s]).	Week 64

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; Crohn's Disease; RINVOQ
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; upadacitinib
• Other Study ID Numbers: M14-671; 2023-509618-12 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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.: Yes