NCT03421197.

Study name	A study to assess the efficacy and safety of PPC‐06 (Tepilamide Fumarate)
Methods	RCT, active/placebo‐controlled, double‐blind study Date of study: January 2018 Location: USA Phase 2
Participants	Randomised: 400 participants Inclusion criteria Generally healthy men or non‐pregnant women age ≥ 18 years at the time of screening (or who have reached the state minimum legal age of consent) Stable, moderate‐to‐severe plaque psoriasis diagnosed for at least 6 months prior to randomisation (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the person) Severity of disease meeting all 3 of the following criteria prior to randomisation (at the baseline [day 0] visit): PASI score of ≥ 12; Total BSA affected by plaque psoriasis of ≥ 10%; IGA score of > 3 Must be a candidate for phototherapy and/or systemic therapy for psoriasis Exclusion criteria Non‐plaque psoriasis (i.e. predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis) Drug‐induced psoriasis or with drug‐exacerbated psoriasis that has not resolved within 4 weeks prior to screening Rreceived systemic non‐biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self‐treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the baseline visit Had topical psoriasis treatment within the previous 2 weeks prior to the baseline visit History of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit: Etanercept ‐ 35 days; Infliximab, adalimumab ‐ 12 weeks; Ustekinumab ‐ 24 weeks; Any other biologic agent < 5 half‐lives prior to the baseline visit History of use of any investigational drug within 28 days prior to randomisation, or 5 pharmacokinetic/pharmacodynamic half‐lives (whichever is longer)
Interventions	Intervention A. Tepilamide fumarate 400 mg tablet once a day Control interventions B. Tepilamide fumarate 400 mg tablet twice a day C. Tepilamide fumarate tablets 600 mg twice a day D. Placebo
Outcomes	At week 24 Primary composite outcome PASI 75 and IGA 0/1 Secondary outcome PASI 50, PASI 75 IGA BSA
Starting date	Study start date: January 2018 Estimated study completion date: March 2020 Last update posted: March 2020, active not recruiting
Contact information	Dr. Reddy's Laboratories Limited Study director: Srinivas Sidgiddi, MD
Notes	Ongoing study Last checked in September 2020