Study comparing risankizumab and Fumaderm, for the treatment of a moderate to severe inflammatory disease of the skin called psoriasis in patients who have never been treated with oral or injectable drugs. Patients will know which drug they receive, the person evaluating the skin will not .
- Conditions
- Plaque PsoriasisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-003718-28-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
1. Male or female subject = 18 and < 80 years of age at the time of screening.
2. Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
3. Subject has stable moderate to severe plaque psoriasis with or without psoriatic arthritis at Baseline
• Has an involved BSA > 10% and
• Has a PASI score > 10 and
• Has a DLQI > 10.
4. Must be naïve to and candidate for systemic therapy, as assessed by the investigator.
5. Subject has an inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.
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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
1. Subjects with
• Non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
• 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 study evaluations according to investigator's judgment
2. Subject has previously received systemic therapy for psoriasis, whether biologic or non-biologic, or photochemotherapy (e.g. PUVA therapy, any UV-therapy or baneotherapy associated with UV-sensitizing agent. 3. Active systemic infections during the last 2 weeks (exception: common cold) prior to screening.
4. 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.
5. Subject has any condition or contraindication to FUMADERM® that would preclude the patient's participation in the present study, including, but not limited to:
• A known hypersensitivity to fumaric acid derivatives or other components of FUMADERM® Initial or FUMADERM®,
• Any parameter of the complete blood count (CBC) outside of normal range according to the central laboratory,
• Severe liver disease (ALT or AST > 2 × ULN according to central laboratory normal range, or total bilirubin > 1.5 × ULN according to central laboratory normal range at Screening visit),
• Severe kidney disease (serum creatinine above normal value according to central laboratory normal range at Screening visit),
• Severe gastro-intestinal disease, such as a known active gastro-duodenal ulcer,
• Inability to understand the complexity of FUMADERM® dosing regimen.
• Any other exclusionary condition provided in Fumaderm® local label.
• Any of the following risk factors for renal toxicity:
-peripheral vascular disease
-diabetes mellitus with microalbuminuria (UACR > 30 mg/g), at Screening visit
-systolic blood pressure measurement of > 140 mmHg or a diastolic blood pressure measurement of > 90 mmHg at the Screening Visit, unless there is confirmation from an Internist or a cardiologist that no renal or cardiovascular risk is associated with the elevated blood pressure.
-history of congestive heart failure (NYHA Class III or IV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM® provided as study medication in subjects with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.;Secondary Objective: Not Applicable;Primary end point(s): proportion of subjects with a = 90% improvement in Psoriasis Area and Severity Index (PASI 90) at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method