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Trial · NCT02409667

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMaintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24Week 52
Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYKey Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24Week 52
FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24week 52
Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24Week 52
Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in PASI in Participants With a PASI 90 Response at Week 24Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in DLQI in Participants With a PASI 90 Response at Week 24Baseline, Week 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Week 52
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24Baseline, Week 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Week 52
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24Baseline, Week 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Week 52
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24Baseline, Week 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Week 52
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24Baseline, Week 52
Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
score on a scaleMEAN
SECONDARYChange From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24Baseline, Week 52
Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
score on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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