AbbVie: Crohn Disease trials

The registry lists 56 Crohn Disease studies with AbbVie as lead sponsor. 8 are open to participants now and 29 have results posted.

Phase 1 1Phase 2 8Phase 3 16Phase 4 2No phase 29(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative ColitisRecruitingNCT07697456Phase 2
• A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World SettingRecruitingNCT07073079
• Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in BelgiumRecruitingNCT06581042
• Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's DiseaseRecruitingNCT06548542Phase 2
• An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in JapanRecruitingNCT06023030
• A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's DiseaseRecruitingNCT05995353Phase 3
• Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved IndicationsRecruitingNCT04846959
• Expanded Access to UpadacitinibAvailableNCT04159597
• A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's DiseaseTerminatedNCT05068284Phase 2Results posted
• A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic TherapiesCompletedNCT03345849Phase 3Results posted
• A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic TherapyCompletedNCT03345836Phase 3Results posted
• A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's DiseaseCompletedNCT03105128Phase 3Results posted
• A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic TreatmentCompletedNCT03104413Phase 3Results posted
• A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's DiseaseCompletedNCT02782663Phase 2Results posted
• Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)CompletedNCT02750800Results posted
• Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"CompletedNCT02578238Results posted
• A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's DiseaseCompletedNCT02513459Phase 2Results posted
• Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's DiseaseCompletedNCT02499783Phase 3Results posted
• An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)CompletedNCT02451839Results posted
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF TherapyCompletedNCT02365649Phase 2Results posted
• Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115CompletedNCT02185014Phase 3Results posted
• Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s DiseaseCompletedNCT02148718Phase 4Results posted
• Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's DiseaseCompletedNCT02065570Phase 3Results posted
• Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.CompletedNCT02031276Phase 2Results posted
• Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's DiseaseCompletedNCT02015793Phase 2Results posted
• A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's DiseaseCompletedNCT01958827Phase 3Results posted
• Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's DiseaseCompletedNCT01860846Results posted
• Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeCompletedNCT01768858Results posted
• An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)CompletedNCT01759264Results posted
• Special Investigation (Long-term Investigation) in Patients With Crohn's DiseaseCompletedNCT01464333Results posted
• Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving AdalimumabCompletedNCT01428115Results posted
• Special Investigation in Patients With Crohn's Disease (All Patients Investigation)CompletedNCT01298648Results posted
• Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's DiseaseCompletedNCT01235689Phase 3Results posted
• Effectiveness and Safety in Patients With Crohn´s Disease in Clinical RoutineCompletedNCT01083680Results posted
• Surveillance of Humira Injection in Korean PatientsCompletedNCT01083121Results posted
• Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806CompletedNCT00686374Phase 3Results posted
• A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)CompletedNCT00524537Results posted
• A Retrospective Study to Evaluate Treat-to-Target and Disease Modification in Adult Participants With Crohn's Disease and Ulcerative Colitis in Real World SettingCompletedNCT07421258
• Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's DiseaseCompletedNCT06459297
• A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel DiseaseCompletedNCT06346288Phase 4
• Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseActive, not recruitingNCT06332534Phase 3
• An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)CompletedNCT06126146
• A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.Active, not recruitingNCT06063967Phase 3
• Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.Active, not recruitingNCT05930275
• An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)Active, not recruitingNCT05841537
• A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)CompletedNCT05394805
• Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)Active, not recruitingNCT04524611Phase 3
• A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseCompletedNCT04254783Phase 1
• Expanded Access to RisankizumabNo longer availableNCT03914261
• A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433Active, not recruitingNCT03345823Phase 3
• Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health ServiceCompletedNCT03223012
• A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's DiseaseActive, not recruitingNCT03105102Phase 3
• A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life ConditionsTerminatedNCT03017014
• Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )CompletedNCT02896985
• A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)Active, not recruitingNCT02130362
• A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell LymphomaWithdrawnNCT02087878