Moderate to severe plaque-type psoriasis MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: AIN457
Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Concentration unit
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: • Males or females at least 18 years of age at time of entry • Diagnosis of chronic plaque-type psoriasis for at least 6 months at time of randomization • At randomization, moderate to severe psoriasis (PASI = 12, IGA = 3, and BSA = 10%) • At screening and randomization, psoriasis considered inadequately controlled by: - topical treatment In addition, patients may have failed to respond to: - phototherapy and/or - previous systemic therapy • Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key exclusion criteria: • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization • Drug-induced psoriasis at randomization (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) • Ongoing use of prohibited psoriasis treatments / medications (e.g., topical or systemic corticosteroids, UV therapy) at randomization • Ongoing use of other prohibited treatments at randomization. All concomitant medication must be on a stable dose for at least four weeks before first study drug administration. • Known immunosuppression (e.g., AIDS) at screening and / or randomization • History or evidence to suggest active TB at screening. All patients will be tested for TB status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent TB may enter the trial after sufficient treatment has been initiated according to local regulations. • Active systemic infections during the last two weeks before randomization (exception: common cold) • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of three induction regimens of AIN457 administered s.c. in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo.;Secondary Objective: Key Secondary objectives: To compare the efficacy of two maintenance regimens of AIN457 with respect to PASI 75 achievement at least once from week 21 to 29 To evaluate the efficacy in three induction regimens of AIN457 administered s.c. as assessed by IGA (static IGA) after 12 weeks of treatment, compared to placebo. To explore the effects of AIN457 treatment as assessed by IGA (static IGA) over time during the trial up to 4 weeks after last study drug administration.;Primary end point(s): The primary endpoint, achievement of PASI 75 at week 13, will be analyzed by Dunnett’s test procedure for proportions in a sequential manner. | — |
Countries
France, Germany, Iceland
Outcome results
None listed