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
Summary description of the study
Crohn's disease (CD) is a chronic inflammatory condition affecting various sections of the intestine. To date, no medical or surgical cure is known for CD. The treatment goals for CD currently include relief of symptoms, reduction of inflammation, and improvement of quality of life. Upadacitinib (ABT-494) is a new drug used in this study. It has been developed for adult patients with inflammatory conditions to control inflammation and relieve symptoms in patients suffering from CD. This study is aimed at patients who participated in study M14-431 or M14-433. It investigates the long-term safety and efficacy of Upadacitinib in patients with CD.
(BASEC)
Intervention under investigation
This study is aimed at patients who participated in study M14-431 or M14-433. It investigates the long-term safety and efficacy of Upadacitinib in patients with CD.
All patients who participated in study M14-431 or M14-433 and showed a response at the end of the 12-week induction phase or the 12-week continuation phase will have the opportunity to participate in study M14-430.
The dose a patient receives depends on which study they participated in and what dose they received. If they met the response criteria and received placebo or a medium dose of Upadacitinib during the first study, this dosing will continue. Patients who received the high dose will be equally assigned to a 52-week treatment with the medium dose, low dose, or placebo. In this part, the study is blinded, so no one knows what dose a patient is receiving. Once patients have completed this phase, they have the opportunity to enter a new 240-week sub-study and continue receiving the same medication as before. Initially, this treatment is blinded and at a certain point then becomes open. Patients receiving placebo who do not show a response after 4 weeks may switch to the low dose of Upadacitinib.
(BASEC)
Disease under investigation
Crohn's disease (CD)
(BASEC)
For Sub-study 1: 1. Patients who received double-blind treatment in study M14-431 or M14-433 and achieved a clinical response. 2. Patients who completed the study measures in the main study. For Sub-study 2: 1. Patients who completed Sub-study 1. 2. Patients who received open Upadacitinib dose B in study M14-431 and achieved a clinical response. 3. Patients who completed the study measures in the main study/sub-study. (BASEC)
Exclusion criteria
1. Patients deemed ineligible for the study by the investigator for any reason. 2. Known hypersensitivity to Upadacitinib or excipients or adverse event during study M14-431 or M14-433 or Sub-study 1 of study M14-430, making the patient ineligible according to the investigator's assessment. 3. Active or chronic recurrent infections, making the patient ineligible according to the investigator's assessment. (BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
AbbVie Inc. North Chicago USA AbbVie AG Cham Switzerland
(BASEC)
Contact
Contact Person Switzerland
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
General Information
AbbVie
(ICTRP)
Scientific Information
AbbVie
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
09.05.2018
(BASEC)
ICTRP Trial ID
NCT03345823 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
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)
Disease under investigation
Crohn's Disease (ICTRP)
Intervention under investigation
Drug: Upadacitinib;Drug: Placebo for Upadacitinib (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
15.11.2017 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
ABBVIE INC., AbbVie (ICTRP)
Secondary trial IDs
2023-504951-29, M14-430 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03345823 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available