A Study to Assess the Efficacy and Safety of Risankizumab 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

11 Oct 2018 → ongoing

Decision date (initial)

2024-06-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506994-36-00

EudraCT number

2016-004676-22

ClinicalTrials.gov

NCT03398135

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenetic, Efficacy, Pharmacokinetic

Sub-study 1: To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) who responded to IV risankizumab induction treatment in Study M16-067.

Sub-study 2: To evaluate the efficacy and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring [TDM] vs clinical assessment [CA] for dose escalation) as maintenance therapy in subjects with moderately to severely active UC who responded to induction treatment in Study M16-067.

Sub-study 3: To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2, or subjects who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or the geo-political conflict in Ukraine and surrounding impacted regions. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.

CTE: To provide Sub-study 3 completers with treatment at sites in countries that require continued treatment in accordance with local regulations until such time when risankizumab is commercially available and/or the subject can access treatment locally. Access is defined as investigational product that is commercially available and/or reasonably accessible to the patient (including but not limited to through insurance or reimbursement coverage, or local access mechanism). Additional objectives are to continue to investigate and evaluate long-term safety data for risankizumab.

Conditions and MedDRA coding

Ulcerative Colitis

Study design 4 periods

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 2

1. Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16 067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, or due to the geo-political conflict in Ukraine and surrounding impacted regions, subjects may be allowed to enroll in Substudy 3 should they meet clinical response.
2. Achieved clinical response at the last visit of Study M16-067.

Exclusion criteria 2

1. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
2. Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 that in the Investigator's judgment makes the subject unsuitable for this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Sub-study 1 and 2: The achievement of clinical remission per Adapted Mayo score at Week 52
2. Sub-study 2: Selected efficacy endpoints as those listed in Sub-study 1 but comparing the Therapeutic Drug Monitoring vs Clinical Assessment arms as exploratory purpose.
3. Sub-study 3: Evaluation of long-term safety
4. There are no efficacy endpoints for CTE.

Secondary endpoints 17

1. The achievement of endoscopic improvement at Week 52.
2. The achievement of histologic endoscopic improvement of the mucosa at Week 52.
3. The achievement of endoscopic remission at Week 52.
4. The achievement of clinical remission per Adapted Mayo score at Week 52 with no corticosteroid use for 90 days.
5. The achievement of clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0.
6. The achievement of no bowel urgency at Week 52
7. The achievement of no abdominal pain at Week 52
8. The achievement of histologic endoscopic mucosal remission at Week 52.
9. The achievement of endoscopic improvement at Week 52 in subjects with endoscopic improvement at Week 0.
10. The achievement of clinical response per Adapted Mayo score at Week 52.
11. Change from Baseline (of induction) to Week 52 in FACIT-Fatigue.
12. Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
13. The achievement of no nocturnal bowel movements at Week 52.
14. The achievement of no tenesmus at Week 52.
15. Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per week.
16. Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms.
17. Exposure adjusted Occurrence of UC-related hospitalizations through Week 52

Investigational products

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

Test 4

Placebo 2

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

Bernhard Dodell

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Bernhard Dodell

Third parties 6

Locations

19 EU/EEA countries · 90 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 134 files

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

Application history

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