CompletedPhase 3

Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

China543 participantsStarted 2017-02-28

Plain-language summary

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects must give a written, signed and dated informed consent.
✓. Men or women at least 18 years of age at time of screening.
✓. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
✓. Moderate to severe psoriasis as defined at Baseline by:
✓. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

✕. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
✕. Drug-induced psoriasis.
✕. Ongoing use of prohibited treatments.
✕. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
✕. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
✕. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)

Timeframe: Week 12

Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)

Timeframe: Week 12

NCT IDNCT03066609

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-21

Results submitted2019-11-14

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects must give a written, signed and dated informed consent.
✓. Men or women at least 18 years of age at time of screening.
✓. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
✓. Moderate to severe psoriasis as defined at Baseline by:
✓. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

✕. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
✕. Drug-induced psoriasis.
✕. Ongoing use of prohibited treatments.
✕. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
✕. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
✕. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.