BI 655066 (risankizumab) compared to placebo and ustekinumab in patients with moderate to severe chronic plaque psoriasis

Phase 1

Conditions: Psoriasis
MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-003622-13-PT

Lead Sponsor: nilfarma - União Internacional de Lab. Farmacêuticos, Lda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Male or female patients with age >= 18 years at screening,

Women of childbearing potential must be ready and able to use highly effective methods of birth control,

Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.

Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
a.Have an involved body surface area (BSA) >= 10% and
b.Have a Psoriasis Area and Severity Index (PASI) score >= 12 and
c.Have a static Physician Global Assessment (sPGA) score of >= 3.

Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator

Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 425
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Patients with:
a. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular),
b. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium),
c. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigators judgment,

Previous exposure to BI 655066,
Previous exposure to ustekinumab (Stelara®),

Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),

Use of any restricted medication , 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, aneurysm removal, stomach ligation),

Known chronic or relevant acute infections including 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 or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix,

Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) 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 is in the opinion of the investigator, is clinically significant and would make the study participant unreliable 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 is pregnant, nursing, or who plans to become pregnant while in the trial,

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial is to assess the efficacy and safety of BI 655066 compared to ustekinumab and placebo in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: Additionally, this trial will assess PK and the emergence of anti-drug antibodies, as well as the influence of study treatment on disease specific biomarkers, psoriatic arthritis, and metabolic risk factors.;Primary end point(s): 1: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 16<br><br>2: Achievement of a sPGA score of clear or almost clear at Week 16<br>;Timepoint(s) of evaluation of this end point: 1: week 16 from first trial medication<br><br>2: week 16 from first trial medication<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Achievement of >= 75% reduction from baseline PASI score (PASI 75) at Week 12<br><br>2: Achievement of a sPGA score of clear or almost clear at Week 12<br><br>3: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16<br><br>4: Achievement of >= 90% reduction from baseline PASI score (PASI 90) at Week 52<br><br>5: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 52<br><br>6: Change from baseline in psoriasis symptoms evaluated using the total score on the PSS at week 16<br><br>7: Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16<br><br>8: Achievement of total score on the PSS of 0 at week 16<br>;Timepoint(s) of evaluation of this end point: 1: week 12<br><br>2: week 12<br><br>3: week 16<br><br>4: week 52<br><br>5: week 52<br><br>6: week 16<br><br>7: week 16<br><br>8: week 16<br>

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