Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02672852
Ethics application status
Date submitted
1/02/2016
Date registered
1/02/2016
Date last updated
9/08/2018

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:
Psoriasis 0 0
Psoriasis 0 0
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 - ABBV-066
Treatment: Drugs - Placebo
Treatment: Drugs - ABBV-066
Treatment: Drugs - Placebo

Experimental: ABBV-066 -

Placebo Comparator: Placebo -

Experimental: ABBV-066 -

Placebo Comparator: Placebo -


Treatment: Drugs: ABBV-066
ABBV-066 administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo for ABBV-066 administered by subcutaneous injection

Treatment: Drugs: ABBV-066
ABBV-066 administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo for ABBV-066 administered by subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI90) at week 16 - PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [1] 0 0
week 16
Primary outcome [2] 0 0
Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 16 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [2] 0 0
Week 16
Primary outcome [3] 0 0
Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 52 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [3] 0 0
Week 52
Primary outcome [4] 0 0
Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI90) at week 16 - PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [4] 0 0
week 16
Primary outcome [5] 0 0
Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 16 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [5] 0 0
Week 16
Primary outcome [6] 0 0
Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 52 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [6] 0 0
Week 52
Secondary outcome [1] 0 0
Achievement of a 75% reduction from baseline PASI score (PASI 75) at week 16 - PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Achievement of 100% reduction from baseline PASI score (PASI100) at week 16 - PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Achievement of an sPGA score of clear(0) at Week 16 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 - The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Achievement of an sPGA score of clear (0) or almost clear (1) at Week 104 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Achievement of a 75% reduction from baseline PASI score (PASI 75) at week 16 - PASI75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Achievement of 100% reduction from baseline PASI score (PASI100) at week 16 - PASI100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Achievement of an sPGA score of clear(0) at Week 16 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 - The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Achievement of an sPGA score of clear (0) or almost clear (1) at Week 104 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [10] 0 0
Week 52

Eligibility
Key inclusion criteria
Inclusion criteria:

- Male or female patients. 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 patient.

- 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 GCP and local legislation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Patients 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, 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 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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
1311.4.61001 Boehringer Ingelheim Investigational Site - Phillip
Recruitment hospital [2] 0 0
1311.4.61003 Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [3] 0 0
1311.4.61004 Boehringer Ingelheim Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
1311.4.61002 Boehringer Ingelheim Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussel
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Liège
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Czechia
State/province [26] 0 0
Nachod
Country [27] 0 0
Czechia
State/province [27] 0 0
Pardubice
Country [28] 0 0
Czechia
State/province [28] 0 0
Prague 3
Country [29] 0 0
France
State/province [29] 0 0
Nice
Country [30] 0 0
France
State/province [30] 0 0
Quimper cedex
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Blankenfeld-Mahlow
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Germany
State/province [34] 0 0
Wuppertal
Country [35] 0 0
Japan
State/province [35] 0 0
Aichi, Nagoya
Country [36] 0 0
Japan
State/province [36] 0 0
Fukuoka, Kurume
Country [37] 0 0
Japan
State/province [37] 0 0
Tochigi, Shimotsuke
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo, Itabashi
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo, Shinagawa
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gwangju
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Pusan
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seongnam
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Boehringer Ingelheim
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week
study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy
and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment
of moderate to severe chronic plaque psoriasis in adult patients. This study will also look
at the maintenance of response following randomly withdrawing treatment from those patients
responding to treatment at week 28, as well as the response to re-treatment for patients who
relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the
influence of study treatment on disease specific markers. In a subset of psoriasis patients
with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be
evaluated to assess improvement.
Trial website
https://clinicaltrials.gov/show/NCT02672852
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

Summary results
Other publications