At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 330 enrolled
Drug / intervention
AK101 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
In Brief
A Phase 2 clinical trial evaluating AK101 and Placebo for Plaque Psoriasis. Completed, enrolled 330 participants across 2 sites.
Detailed Summary
This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
CountriesChina
CollaboratorsAkeso Tiancheng, Inc
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartDec 2019
Primary CompletionMar 2022
TodayJul 2026
First PostedNov 22, 2019
Enrollment StartDec 19, 2019
Primary CompletionMar 3, 2022
TodayJul 1, 2026
Enrollment to primary: 2.2 yearsPosted 6.6 years ago
Interventions
AK101biological
an anti-IL-12/23p40 monoclonal antibody
Placebobiological
matching placebo