Multicenter, randomized, double-blind, placebo-controlled maintenance and long-term extension study of the efficacy and safety of Upadacitinib (ABT-494) in patients with Crohn's disease who have completed studies M14-431 or M14-433

American Samoa, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States (ICTRP)

ICTRP Studien-ID
NCT03345823 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Who Completed the Studies M14-431 or M14-433 (BASEC)

Wissenschaftlicher Titel
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433 (ICTRP)

Öffentlicher Titel
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 M14-433 (ICTRP)

Untersuchte Krankheit(en)
Crohn's Disease (ICTRP)

Untersuchte Intervention
Drug: Upadacitinib;Drug: Placebo for Upadacitinib (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Ein-/Ausschlusskriterien
Gender: All
Maximum age: 75 Years
Minimum age: 18 Years
Inclusion Criteria:

For Substudy 1:

- Participant who achieve clinical response in Study M14-431 or Study M14-433.

- Participant completes study procedures in the parent study. The final endoscopy for
Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed
during the COVID-19 pandemic.

For Substudy 2:

- Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the
endoscopy cannot be performed during the COVID-19 pandemic.

- Participant who achieved clinical response at the time described in the protocol and
completes study procedures in the parent study/ substudy.

Exclusion Criteria:

For Substudies 1 and 2:

- Participant is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.

- Participant who has a known hypersensitivity to upadacitinib or its excipients, or
had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study
M14-430 that in the investigator's judgment makes the participant unsuitable for
this study.

- Participant at the final visit of M14-431 or M14-433 with any active or chronic
recurring infections based on the investigator's assessment that makes the
participant an unsuitable candidate for the study. Participants with serious
infections undergoing treatment may be enrolled BUT NOT dosed until the infection
treatment has been completed and the infection is resolved, based on the
investigator's assessment.

- Participants with high grade colonic dysplasia or malignancy diagnosed at the
endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of
Study M14-430 (Week 52). (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI);Sub-Study 1: Percentage of Participants with Endoscopic Response;Number of Participants with Adverse Events (ICTRP)

Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs);Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100);Sub-Study 1: Percentage of Participants with Endoscopic Remission;Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants;Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission;Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI;Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.;Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ);Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F);Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD);Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline (ICTRP)

Registrierungsdatum
15.11.2017 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
ABBVIE INC., AbbVie (ICTRP)

Sekundäre IDs
2023-504951-29, M14-430 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03345823 (ICTRP)