BI 655066 dose ranging in psoriasis, active comparator ustekinumab

Conditions: Psoriasis
MedDRA version: 17.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-004384-48-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 190

Inclusion Criteria

- Body Mass Index (BMI) = 18.5 and < 40 kg/m²
- Patients with stable moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis involving >/= 10% body surface area, with disease severity PASI >/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit and visit 2 (randomisation), as assessed by the investigator
- Psoriasis disease duration of at least 6 months prior to screening, as assessed by the investigator
- Patients must be candidates for systemic psoriasis treatment or phototherapy, as assessed by the investigator
- Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in the local labelling
- Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Patients with guttate, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion criterion)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study.
- Clinically important acute or chronic infections including hepatitis, HIV and tuberculosis (including latent tuberculosis), or a positive interferon gamma release assay (IGRA) testing for tuberculosis
- Have had a live vaccination >/= 12 weeks prior to randomisation (visit 2). Patients must agree not to receive a live vaccination during the study. No BCG vaccines should be given for one year prior to randomisation (visit 2), during the study and for one year after last administration of study drug (according to the Stelara® SPC).
- History of clinically significant hypersensitivity to a systemically administered biologic agent or its excipients
- History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
- Has received any therapeutic agent directly targeted to IL-12, IL-23 (including ustekinumab (Stelara®)
- Use of biologic agents within 12 weeks (infliximab, etanercept, adalimumab, other biologics) prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications within 2 weeks prior to treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to compare efficacy of BI 655066 versus ustekinumab at week 12, based on PASI90 response.;Secondary Objective: To compare efficacy of BI 655066 versus ustekinumab at week 12, based on PASI75, PASI100, PASI50, sPGA clear or almost clear, PASI reduction, and to compare efficacy at week 24, based on PASI90, and time to loss of PASI50 response.;Primary end point(s): 1: Achievement of >/= 90% reduction from baseline PASI score (PASI90) at week 12<br>;Timepoint(s) of evaluation of this end point: 1: 12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Achievement of >/=75% reduction from baseline in PASI score (PASI75) at week 12 and 24<br><br>2: Achievement of 100% reduction from baseline in PASI score (PASI100) at week 12<br><br>3: Achievement of >/= 50% reduction from baseline in PASI score (PASI50) at week 12<br><br>4: Achievement of PASI90 at week 24<br><br>5: Achievement of sPGA clear or almost clear at week 12<br><br>6: Percentage of PASI reduction from baseline at week 12<br><br>7: Time to loss of PASI50 response. This endpoint is calculated from the first treatment to first < 50% reduction of PASI score compared with baseline after the response has been achieved<br>;Timepoint(s) of evaluation of this end point: 1: 24 weeks<br><br>2: 12 weeks<br><br>3: 12 weeks<br><br>4: 24 weeks<br><br>5: 12 weeks<br><br>6: 12 weeks<br><br>7: up to 48 weeks<br>

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