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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03105102




Registration number
NCT03105102
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
8/10/2024

Titles & IDs
Public title
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2016-003191-50
Secondary ID [2] 0 0
M16-000
Universal Trial Number (UTN)
Trial acronym
FORTIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo for Risankizumab SC
Treatment: Drugs - Risankizumab IV
Treatment: Drugs - Placebo for Risankizumab IV
Treatment: Drugs - Risankizumab SC
Treatment: Drugs - Risankizumab On-Body Injector (OBI)

Placebo comparator: Double-blind Placebo for Risankizumab (Sub-Study 1) - Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.

Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.

Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1) - Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.

Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2) - Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2) - Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Open-label Risankizumab (Sub-Study 3) - Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.

Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4) - Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.

Experimental: CTE: Open Label Continuous Treatment Extension - Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.


Treatment: Drugs: Placebo for Risankizumab SC
Placebo for Risankizumab SC Subcutaneous (SC) Injection

Treatment: Drugs: Risankizumab IV
Risankizumab IV Intravenous (IV) infusion

Treatment: Drugs: Placebo for Risankizumab IV
Placebo for Risankizumab IV Intravenous (IV) infusion

Treatment: Drugs: Risankizumab SC
Risankizumab SC Subcutaneous (SC) injection

Treatment: Drugs: Risankizumab On-Body Injector (OBI)
Subcutaneous (SC) injection; on-body injector (OBI)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Sub-Study 1: Percentage of Participants With Endoscopic Response
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Sub-Study 3: Number of Participants With Adverse Events
Timepoint [3] 0 0
Up to Week 220
Primary outcome [4] 0 0
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
Timepoint [4] 0 0
Up to Week 16
Primary outcome [5] 0 0
Sub-Study 4: Percentage of Participants who had no Potential Hazards
Timepoint [5] 0 0
Up to Week 16
Primary outcome [6] 0 0
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
Timepoint [6] 0 0
Up to Week 16
Primary outcome [7] 0 0
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Timepoint [7] 0 0
Up to Week 16
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants With Clinical Remission
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Percentage of Participants With Deep Remission
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Timepoint [12] 0 0
Up to Week 52

Eligibility
Key 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).
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2026
Actual
Sample size
Target
Accrual to date
Final
1336
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Limited /ID# 167220 - South Brisbane
Recruitment hospital [2] 0 0
Griffith University /ID# 212635 - Southport
Recruitment hospital [3] 0 0
Lyell McEwin Hospital /ID# 212215 - Elizabeth Vale
Recruitment hospital [4] 0 0
Emeritus Research /ID# 213512 - Camberwell
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4222 - Southport
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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California
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United States of America
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Colorado
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Connecticut
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study consists of 4 sub-studies, as follows:

* Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab 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 risankizumab 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 risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
* Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
* OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Trial website
https://clinicaltrials.gov/study/NCT03105102
Trial related presentations / publications
Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03105102