Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: RO5459072/F03
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
CAS Number: 1252637-35-6
Current Sponsor code: RO5459072
Other descriptive name: RO5459072
Concentrat
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be between 18 and 75 years of age inclusive, at the time of signing the informed consent - Participants must have a >= 6 month history of plaque psoriasis or pustular psoriasis as confirmed by a dermatologist, with a Psoriasis Area and Severity Index (PASI) score > 10, and a body surface area (BSA) involvement > 10% - For female participants: Agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method that results in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: - Present with clinically significant underlying disease processes, such as: cancer within the past 5 years, chronic systemic autoimmune condition, severe cardiovascular and respiratory disease any other severe condition that requires intensive treatment - Any condition, including lab abnormalities, which places the patient at unacceptable risk if the patient were to participate in the study, or may confound the interpretation of trial data - Patients who have current erythrodermic or guttate psoriasis - Patients who have drug-induced psoriasis - Patients treated with any of the following systemic therapies including phototherapy, within 28 days of first study drug dosing, including JAK inhibitors, PDE-4 inhibitors, topical or systemic glucocorticosteriods, retinoids and/or ultraviolet (UV) therapy, and other non-psoriasis prohibited treatments defined in the protocol - Patients who received adalimumab, infliximab, tocilizumab, canakinumab, or secukinumab within 4 months of first study drug dosing - Patients who received etanercept or anakinra within 56 days of first study drug dosing - B cell depleting antibodies are prohibited during the study - Patients who received ustekinumab within 6 months of first study drug dosing. - Patients who, upon previous exposure to any of the following treatments failed to show any clinical benefit in the investigator's opinion: alefacept, etanercept, efalizumab, infliximab, secukinumab, ustekinumab, or adalimumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Assess the efficacy of RO5459072 in clearing psoriatic skin ;Secondary Objective: •Assess early efficacy of RO5459072 after six weeks of treatment •Assess sustained efficacy of RO5459072 after a four week follow-up period •Assess the efficacy of RO5459072 in improving the quality of life as measured by the Dermatology Life Quality Index (DLQI) •Assess the safety and tolerability of RO5459072 given over twelve weeks •Pharmacokinetics (PK) of RO5459072 in psoriatic participants ;Primary end point(s): 1. The proportion of participants that achieve a psoriasis area and severity index (PASI)75 (PASI75) response after twelve weeks of treatment;Timepoint(s) of evaluation of this end point: 1. Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of participants that achieve a PASI50, PASI75, and PASI90 response after six weeks and twelve weeks of treatment, and four weeks after completion of treatment 2. Change of PASI from baseline after six weeks and twelve weeks of treatment, and four weeks after completion of treatment 3. Change of physician’s global assessment score (sIGA) after six weeks and twelve weeks of treatment, and four weeks after completion of treatment 4. Change of DLQI after six weeks and twelve weeks of treatment, and four weeks after completion of treatment 5. Incidence of Adverse events 6. Changes in clinical laboratory values, physical examinations, vital signs, and electrocardiogram (ECG) 7. AUC (area under the curve) of RO5459072 8. Cmax (maximum concentration) of RO5459072 ;Timepoint(s) of evaluation of this end point: 1-3. At baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment 4. At baseline (Day 1), Week 6, Week 12, Week 4 after completion of treatment 5-6. Up to 20 weeks 7-8. At baseline (Day 1), Week 6 and Week 12 | — |
Countries
Germany, Ukraine
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed