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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2014-005102-38
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Secondary ID [2]
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M15-992
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
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Assessment method [1]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
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Timepoint [1]
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Baseline, Week 16
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Primary outcome [2]
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
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Assessment method [2]
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean =1.5, <2.5; Moderate (3) = mean =2.5, <3.5; and Severe (4) = mean =3.5. NRI was used for missing data.
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Timepoint [2]
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Week 16
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Primary outcome [3]
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Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
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Assessment method [3]
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean =1.5, <2.5; Moderate (3) = mean =2.5, <3.5; and Severe (4) = mean =3.5. NRI was used for missing data.
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Timepoint [3]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
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Assessment method [1]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
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Assessment method [2]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants Achieving an sPGA Score of Clear at Week 16
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Assessment method [3]
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean =1.5, <2.5; Moderate (3) = mean =2.5, <3.5; and Severe (4) = mean =3.5. NRI was used for missing data.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
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Assessment method [4]
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The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
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Assessment method [5]
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean =1.5, <2.5; Moderate (3) = mean =2.5, <3.5; and Severe (4) = mean =3.5. NRI was used for missing data.
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Timepoint [5]
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Week 104
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Secondary outcome [6]
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Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
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Assessment method [6]
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0
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
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Assessment method [7]
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
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Assessment method [8]
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0
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
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Timepoint [8]
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Week 52
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/07/2018
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Sample size
Target
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Accrual to date
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Final
507
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02672852
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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 not provided in
https://clinicaltrials.gov/ct2/show/NCT02672852
Download to PDF