Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
33
Countries
6
Sites
10
Crohn's Disease (CD)
To observe the long-term efficacy, safety, and tolerability of repeated administration of upadacitinib in subjects with Crohn's disease (CD) who completed Study M13-740
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 11 Oct 2016 → 18 Jul 2025
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2024-510727-19-00
- EudraCT number
- 2015-003759-23
- ClinicalTrials.gov
- NCT02782663
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To observe the long-term efficacy, safety, and tolerability of repeated administration of upadacitinib in subjects with Crohn's disease (CD) who completed Study M13-740
Conditions and MedDRA coding
Crohn's Disease (CD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10013099 | Disease Crohns | 10017947 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | 96 month follow-up period 96 month follow up period to observe the long-term efficacy, safety, and tolerability of upadacitinib
|
Not Applicable | None | Upadacitinib (ABT-494) Dose A: Open label dose A once daily (QD) Upadacitinib (ABT-494) Dose B: Open label dose B QD |
Regulatory references
- Plan to share 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. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
| EU CT number | Title | Sponsor |
|---|---|---|
| 2014-003240-12 | 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 Anti-TNF Therapy., Estudio multicéntrico, aleatorizado, con doble enmascaramiento y controlado con placebo sobre ABT-494 para inducir la remisión sintomática y endoscópica en pacientes con enfermedad de Crohn activa de intensidad moderada a grave que han respondido de forma insuficiente al tratamiento anti-TNF o que no toleran el tratamiento, Multicentrické randomizované dvojitě zaslepené placebem kontrolované klinické hodnocení přípravku ABT-494 podávaného k vyvolání symptomatické a endoskopicky potvrzené remise u pacientů se středně závažnou až závažnou aktivní Crohnovou chorobou, kteří nereagují dostatečně na imunomodulační léčbu nebo na léčbu proti faktoru TNF nebo ji nesnášejí., Multicentrické randomizované dvojitě zaslepené placebem kontrolované klinické hodnocení přípravku ABT-494 podávaného k vyvolání symptomatické a endoskopicky potvrzené remise u pacientů se středně závažnou až závažnou aktivní Crohnovou chorobou, kteří nereagují dostatečně na léčbu proti faktoru TNF nebo ji nesnášejí, Multicentrické randomizované dvojitě zaslepené placebem kontrolované klinické hodnocení přípravku ABT-494 podávaného k vyvolání symptomatické a endoskopicky potvrzené remise u pacientů se středně závažnou až závažnou aktivní Crohnovou chorobou, kteří nereagují dostatečně na léčbu proti faktoru TNF nebo ji nesnášejí, Uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo di ABT-494 per l’induzione della remissione sintomatica ed endoscopica in soggetti affetti da morbo di Crohn da moderatamente a gravemente attivo che hanno risposto in modo inadeguato o sono intolleranti alla terapia anti-TNF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participant must have completed Study M13-740 through Week 52.
- If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
Exclusion criteria 3
- For any reason participant is considered by the investigator to be an unsuitable candidate
- Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
- Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 19
- Proportion of subjects achieving Remission at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects in Remission at Week 0 who maintain remission at Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects achieving Response at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects achieving Clinical Remission over time
- Proportion of subjects achieving modified Clinical Remission over time
- Proportion of subjects achieving enhanced Clinical Response over time
- Proportion of subjects achieving Clinical Response over time
- Proportion of subjects achieving Endoscopic Remission at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects in Endoscopic Remission at Week 0 who maintain Endoscopic Remission at Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects achieving Endoscopic improvement at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects achieving Endoscopic Response at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects achieving Crohn's Disease Activity Index (CDAI) remission over time
- Proportion of subjects achieving CDAI response over time
- Proportion of subjects achieving Enhanced CDAI response over time
- Proportion of subjects achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission over time
- Proportion of subjects achieving IBDQ response over time
- Proportion of subjects taking steroids at Baseline (of Study M13-740) who are steroid-free over time
- Proportion of subjects taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission
- Proportion of subjects achieving Remission and normal C-reactive protein on Months 12, 24, 36, 48, 60, 72, 84, and 96
Secondary endpoints 18
- Time to dose escalation
- Proportion of subjects who require dose escalation to upadacitinib 30 mg QD during this study
- Change from Baseline (of Study M13-740) in the average daily very soft/liquid stool frequency at every visit
- Change from Baseline (of Study M13-740) in average daily abdominal pain at every visit
- Change from Baseline (of Study M13-740) in CDAI at every visit
- Change from Baseline (of Study M13-740) in hs-CRP at every visit
- Change from Baseline (of Study M13-740) in fecal calprotectin at every visit.
- Change from Baseline (of Study M13-740) in Simple Endoscopic Score for Crohn's Disease at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal calprotectin < 250 μg/g at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
- Proportion of subjects who were taking corticosteroids at Week 0 of Study M13-740 who discontinue corticosteroid use and achieved Remission over time.
- Change from Baseline of Study M13-740 in IBDQ over time
- Change from Baseline of Study M13-740 in EuroQol Dimensions 5 Levels over time
- Change from Baseline of Study M13-740 in Work Productivity and Impairment Questionnaire (WPAI) over time
- Proportion of subjects with CD-related hospitalization
- Proportion of subjects with CD-related surgeries and procedures
- The proportion of subjects with no draining fistulas over time
- Changes in extraintestinal manifestations over time.
- For analyses purposes, the baseline data for each subject will be the data collected immediately prior to starting double-blind-treatment of Study M13-740.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD3232825 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 43200 mg milligram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD3232826 · Product
- Active substance
- Upadacitinib
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 86400 mg milligram(s)
- Max treatment duration
- 96 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Raleigh, United States | Interactive response technologies (IRT) |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
6 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 1 | 1 |
| France | Ended | 2 | 2 |
| Germany | Ended | 2 | 2 |
| Netherlands | Ended | 4 | 2 |
| Poland | Ended | 2 | 2 |
| Slovakia | Ended | 1 | 1 |
| Rest of world
Israel, New Zealand, Canada, United States, United Kingdom
|
— | 21 | — |
Investigational sites
Centre Hospitalier Universitaire Amiens Picardie
SERVICE D’HEPATO GASTROENTEROLOGIE, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHRU De Nancy
Gastro-entérologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Medizinisches Versorgungszentrum Portal 10
N/A, Albersloher Weg 10b, 48155, Muenster
Universitaetsklinikum Schleswig-Holstein AöR
N/A, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitair Medisch Centrum Utrecht
Gastrointestinal tract, Heidelberglaan 100, 3584 CX, Utrecht
Academisch Medisch Centrum
Gastrointestinal tract, Meibergdreef 9, 1105 AZ, Amsterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2016-12-29 | 2025-03-03 | 2017-01-11 | 2017-08-24 | |
| France | 2016-12-12 | 2024-04-23 | 2016-12-27 | 2017-08-24 | |
| Germany | 2017-01-25 | 2025-04-03 | 2017-01-26 | 2017-08-24 | |
| Netherlands | 2017-02-07 | 2025-07-15 | 2017-02-07 | 2017-08-24 | |
| Poland | 2017-04-03 | 2025-06-06 | 2017-04-05 | 2017-08-24 | |
| Slovakia | 2016-10-11 | 2024-11-21 | 2016-10-11 | 2017-08-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m14327-protocol-redacted | 7.1 |
| Recruitment arrangements (for publication) | EU CTR Blank Document | 1.0 |
| Recruitment arrangements (for publication) | EU CTR Blank Document | 2 |
| Subject information and informed consent form (for publication) | L1_M14-327 NL _Addendum ICF_Public Clean | 10 |
| Subject information and informed consent form (for publication) | M14-327 NL - ICF Main Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | M14-327 NL - ICF Preg Part Dutch_Public | 2.2 |
| Subject information and informed consent form (for publication) | M14-327 PL ICF Addendum_Public | 1 |
| Subject information and informed consent form (for publication) | M14-327 PL ICF Main_Public | 10 |
| Subject information and informed consent form (for publication) | M14-327 PL ICF Pregnant Partner_Public | 2 |
| Synopsis of the protocol (for publication) | D1_m14327-protocol synopsis | 7.1 |
| Synopsis of the protocol (for publication) | D1_m14327-protocol synopsis-lay version | 1 |
| Synopsis of the protocol (for publication) | D1_m14327-protocol synopsis-lay version-NL-NL | 1 |
| Synopsis of the protocol (for publication) | D1_m14327-protocol synopsis-PL-PL | 7.1 |
| Synopsis of the protocol (for publication) | m14-327-protocol-synopsis-fr_public | 7 |
| Synopsis of the protocol (for publication) | m14-327-protocol-synopsis-sl_public | 7 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | France | Acceptable 2024-06-24
|
2024-06-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-16 | Acceptable 2024-06-24
|
2024-09-16 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-16 | France | Acceptable 2024-06-24
|
2024-09-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Acceptable 2025-07-01
|
2025-07-08 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-28 | France | Acceptable 2025-07-01
|
2025-07-28 |