Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

2 Jan 2017 → ongoing

Decision date (initial)

2023-12-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc

External identifiers

EU CT number

2023-505699-31-00

EudraCT number

2016-000674-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the Long-Term Safety and Efficacy of ABT-494

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

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/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Main study inclusion criteria include subjects who have not responded at the end of the induction period (Week 8) in Study M14-234 (Substudy 1), who has had lost of response during the maintenance period of Study M14-234 (Substudy 3), or who has completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for subjects with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in studies M14-234 SS2, SS3 and M14-675 those following subjects may be enrolled if the below criteria are met: Subjects who achieved clinical response defined by Partial Adapted Mayo Score at Week 8 of Studies M14-234 SS2 and M14-675Subjects who achieved clinical response defined by Partial Adapted Mayo Score at Week 16 in the extended treatment period of Studies M14-234 SS2 and M14-675 Note: If endoscopy is missing at Week 8 but can be performed at Week 16, Week 16 endoscopy should be performed. However, the status of clinical response will be defined by Partial Adapted Mayo Score and clinical responders may enter Study M14-533 Cohort 1. ●Subjects who have completed the 52-week treatment in Study M14- 234 SS3 if the PI considers it is safe to continue based on phone/video call, subject's medical history and findings from the last endoscopy.
2. Women of childbearing potential (refer to Section 5.2.4) must have a negative urine pregnancy test at Week 0 visit.
3. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations
4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding studies.
5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion criteria 12

1. For any reason subject is considered by the investigator to be an unsuitable candidate.
2. Current evidence of active tuberculosis; Current evidence of latent tuberculosis and for any reason the subject cannot take full course of TB prophylaxis treatment as required per protocol.
3. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
4. Subjects have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of the preceding studies.
5. History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in the preceding studies.
6. Laboratory values immediately prior to Week 0 of Study M14-533 meeting the toxicity management criteria for discontinuation (Section 6.1.7). Subjects with laboratory values meeting criteria for interruption may be enrolled BUT NOT dosed until guidelines for restarting study drug are met (Section 6.1.7, Table 5).
7. Female subject with a positive pregnancy test at Baseline (final visit of the preceding studies) or who is considering becoming pregnant during the study and within 30 days after the last dose of study drug.
8. Known hypersensitivity to upadacitinib or its excipients or had any AE during the preceding studies, that in the investigator's judgment makes the subject unsuitable for this study.
9. Subject is not in compliance with prior and concomitant medication requirements and procedures throughout the preceding studies.
10. Anticipated requirement or receipt of any live vaccine with replicating potential during study participation including up to 30 days (or longer if required locally) (8 weeks for subjects in Japan) after the last dose of study drug. Live vaccines that are incapable of replicating (e.g., JYNNEOS monkeypox vaccine) are permitted.
11. Enrollment in another interventional clinical study while participating in this study.
12. Subject with an active or recurrent infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of adverse events (AEs) will be assessed for the Main Study. Changes from the LTE Baseline over time in vital signs, physical examination and clinical laboratory results will also be assessed.

Secondary endpoints 1

1. Efficacy endpoint of Main study: Proportion of subjects achieving clinical remission per Adapted Mayo score (defined as SFS ≤ 1 and not greater than baseline, RBS of 0, and end.oscopy subscore ≤ 1) at Week 0, Week 48, and every 48 weeks thereafter.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

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 5

Locations

20 EU/EEA countries · 69 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 141 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications