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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02672852




Registration number
NCT02672852
Ethics application status
Date submitted
1/02/2016
Date registered
3/02/2016
Date last updated
9/10/2019

Titles & IDs
Public title
BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Scientific title
BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
Secondary ID [1] 0 0
2014-005102-38
Secondary ID [2] 0 0
M15-992
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Risankizumab
Treatment: Drugs - Placebo

Experimental: Risankizumab - Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Placebo Comparator: Placebo - Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).


Treatment: Drugs: Risankizumab
Risankizumab administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo for risankizumab administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
Timepoint [1] 0 0
Baseline, Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Timepoint [2] 0 0
Week 16
Primary outcome [3] 0 0
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
Timepoint [3] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
Timepoint [5] 0 0
Week 104
Secondary outcome [6] 0 0
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
Timepoint [8] 0 0
Week 52

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
* Age =18 years at screening
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant.
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) = 10% and Have a Psoriasis Area and Severity Index (PASI) = 12 and Have a static Physician Global Assessment (sPGA) score of = 3.
* Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
* Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
* Previous exposure to ABBV-066
* Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
* Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
* Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation).
* Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
* History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Previous enrolment in this trial

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2018
Sample size
Target
Accrual to date
Final
507
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02672852