Secukinumab
Biological150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
NCT Number: NCT02362789
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Novartis Investigative Site, Bad Bentheim, Germany
All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)
Time frame: Week 32
On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.
Novartis Pharmaceuticals
Industry
Exploratory Study on the Kinetics of Psoriasis Symptoms, Pruritus Intensity and Lesional Biomarkers in Patients With Moderate to Severe Plaque-type Psoriasis Treated With Subcutaneous Secukinumab (300 mg) During a 16 Week Open-label run-in Phase Followed by a 16 Week Randomized, Double-blind, Placebo-controlled Withdrawal Phase
Acronym: PSORITUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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