NCT02474082

Trial name or title	Study of secukinumab compared to Fumaderm® in adults with moderate to severe psoriasis (PRIME)
Methods	RCT, active‐controlled, open‐label study Date of study: June 2015 ‐ Location: USA Phase 3
Participants	Randomised: 202 participants Inclusion criteria Men or women must be ≥ 18 years of age at the time of screening Chronic plaque‐type psoriasis diagnosed for ≥ 6 months before randomisation. Patients with moderate‐severe plaque psoriasis who are candidates for systemic therapy as defined at randomisation by: PASI score of > 10 BSA) > 10% DLQI > 10 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 Exclusion criteria Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline Ongoing use of other prohibited psoriasis and non‐psoriasis treatment Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations Severe liver diseases Severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers Severe kidney diseases or serum creatinine above 1 x ULN Known hematological disease or lab abnormalities Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)
Interventions	Intervention Secukinumab (300 mg at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20) Control intervention Fumaderm® (week 0: 1 tablet of Fumaderm® INITIAL in the evening Week 1: 1 tablet Fumaderm® INITIAL, in the morning and evening Week 2: 1 tablet Fumaderm® INITIAL in the morning, at noon and in the evening until the last tablet of a 40‐tablet‐blister is consumed Week 2‐3: At the day after the last tablet of the Fumaderm® INITIAL 40‐tablet‐blister is consumed and through week 3, 1 tablet of Fumaderm® in the evening Week 4: 1 tablet Fumaderm® in the morning and evening Week 5: 1 tablet Fumaderm® in the morning, at noon and in the evening Week 6: 1 tablet of Fumaderm® in the morning and at noon, 2 tablets of Fumaderm® in the evening Week 7: 2 tablets of Fumaderm® in the morning, 1 tablet of Fumaderm® at noon, 2 tablets of Fumaderm® in the evening Weeks 8‐24: 2 tablets of Fumaderm® in the morning, at noon and in the evening)
Outcomes	At week 24 Primary outcome PASI 75 Secondary outcomes PASI 90 IGA 0/1 DLQI
Starting date	Study starting date: April 2015 Study completion date: June 2016
Contact information	Novartis Pharmaceuticals
Notes	Ongoing study