A Placebo controlled Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease

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

8 Nov 2017 → ongoing

Decision date (initial)

2024-08-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-506399-28-00

EudraCT number

2016-003191-50

ClinicalTrials.gov

NCT03105102

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Sub-Study 1 (SS1): Randomized, double-blind, placebo-controlled maintenance.
To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active CD who responded to IV risankizumab induction treatment in Study M16-006 or Study M15-991 and had a Baseline of induction eligibility SES-CD of ≥6 (≥4 for isolated ileal disease).

Sub-Study 2 (SS2): Randomized, exploratory maintenance.
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 CD who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-Study 3 (SS3): Open-label (OL) long term extension.
To evaluate long-term safety of risankizumab in subjects who completed SS 1, 2, or subjects who enroll directly into SS3 (from either induction studies or another AbbVie risankizumab Crohn's disease study). Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.

Continuous Treatment Extension (CTE): OL CTE
To provide SS 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. Additional objectives are to continue to investigate and evaluate long-term safety data for risankizumab.

Conditions and MedDRA coding

Crohn's Disease

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 3

1. Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
2. Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
3. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol, including self-administration or care-giver administration of SC injections (if allowed per local requirements).

Exclusion criteria 6

1. Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
2. Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
3. Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
4. Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
5. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
6. Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. SS1: Proportion of subjects with clinical remission at Week 52
2. SS1: Proportion of subjects with endoscopic response at Week 52
3. SS3: Evaluation of Long-term safety

Secondary endpoints 13

1. Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52
2. Proportion of subjects with clinical remission at Week 52 among the subjects with clinical remission in Week 0
3. Proportion of subjects with ulcer-free endoscopy at Week 52
4. Proportion of subjects with endoscopic remission at Week 52
5. Mean change of IBDQ total score at Week 52 from baseline of induction
6. Mean change of FACIT fatigue at Week 52 from baseline of induction
7. Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction).
8. Proportion of subjects with CDAI clinical response at Week 52
9. Proportion of subjects with clinical remission and endoscopic response at Week 52
10. Proportion of subjects with enhanced clinical response at Week 52
11. Proportion of subjects with deep remission at Week 52
12. Exposure adjusted occurrence of CD-related hospitalizations from Week 0 through Week 52
13. Change from baseline of the induction study in Short Form-36 (SF- 36) Physical Component Summary score at 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

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 7

Locations

22 EU/EEA countries · 102 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 152 files

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

Application history

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