NCT03105102

A Study of the Efficacy and Safety of an Active Drug in Participants With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

Brief summary

The study consists of 3 sub-studies, as follows:

- Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of an active drug versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to an active drug induction treatment in Study M16-006 or Study M15-991

- Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for an active drug as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;

- Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of an active drug in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989.

Interventional study

Status:
Active, not recruiting
Conditions:
Crohn's Disease
Enrollment:
1336 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-000
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 16 Years to 80 Years.

Inclusion Criteria:

- Participants who have entered and completed Study M16-006 or Study M15-991 or other
AbbVie risankizumab Crohn's disease study.

- Participants have completed the study M16-006 or M15-991 and have achieved clinical
response.

- Sub-Study 4:

- Participants receiving maintenance treatment in Sub-study 3 and willing to comply
with the requirements of Sub-study 4, including self-administration of
sub-cutaneous injections using the on-body injector (OBI).

- Participant has received at least 16 weeks of stable dosing with risankizumab in
Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the
72-week mark).

Exclusion Criteria:

- 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.

- 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.

- 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.

- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study
M15-991 or another AbbVie risankizumab Crohn's disease study.

- Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
and/or splenomegaly.

- Any active or chronic recurring infections based on the Investigator's assessment
makes the participant an unsuitable candidate for the study.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 2X8
Edmonton - T5R 1W2
New Westminster - V3L 3W4
Vancouver - V6Z 2K5
Victoria - V8V 3M9
Halifax - B3K 6R8
Halifax - B3H 2Y9
Hamilton - L8S 4K1
London - N6A 5W9
North Bay - P1B 2H3
Sudbury - P3A 1W8
Toronto - M5G 1X5
Vaughan - L4L 4Y7
Greenfield Park - J4V 2H1
Levis - G6V 3Z1
Montreal - H1T 2M4
Montreal - H4A 3J1