BI 655066 (risankizumab) compared to active comparator (adalimumab) in patients with moderate to severe chronic plaque psoriasis
- Conditions
- psoriasisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003623-65-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
- 600
- Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
*Women of childbearing potential are defined as:
--having experienced menarche and
--not postmenopausal (12 months with no menses without an alternative medical cause) and
--not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
- Age >= 18 years at screening.
- Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for 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) score >= 12 and
-- 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 candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
- Must be able and willing to self-administer the study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Patients with
-- non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
-- current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
-- active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment.
- Previous exposure to BI 655066.
- Previous exposure to adalimumab (Humira®).
- Currently enrolled in another investigational study or less than 30 days (check also with restricted medication table 4.2.2.1: 1) from screening since completing another investigational drug or device study.
- Use of any restricted medication as specified in Table 4.2.2.1:1 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; confirmation of these diseases testing is required at screening. QuantiFERON® TB test or PPD skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell 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 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 are pregnant, nursing, or who plan to become pregnant while in the trial.
- Previous enrolment in this trial.
- Employees of the sponsor or a participating study site, family members (e.g. spouse, parents, children, siblings) or any other persons who are in a relationship of dependency with the sponsor or any participating study site.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and efficacy of BI 655066 compared to adalimumab in patients with moderate to severe plaque psoriasis.;Secondary Objective: To evaluate the safety and efficacy of BI 655066 after inadequate adalimumab treatment response;Primary end point(s): 1: Achievement of >=90% reduction from baseline PASI score (PASI 90) at Week 16<br><br>2: Achievement of an sPGA score of clear or almost clear at Week 16<br>;Timepoint(s) of evaluation of this end point: 1: 16 weeks<br><br>2: 16 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Achievement of >=75% reduction from baseline PASI score (PASI 75) at Week 16<br><br>2: Achievement of 100% reduction from baseline PASI score (PASI 100) at Week 16<br><br>3: Achievement of >=90% reduction from baseline PASI score (PASI 90) at Week 44 for those patients who were re-randomized at Week 16<br><br>4: Achievement of an sPGA score of clear or almost clear (0 or 1) at Week 44<br><br>5: Achievement of sPGA score of clear (0) at Week 44<br>;Timepoint(s) of evaluation of this end point: 1: 16 weeks<br>2: 16 weeks<br><br>3: 44 weeks<br>4: 44 weeks<br>5: 44 weeks