Clinical trial NCT05504317: A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis

Detailed description: This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..

Eligibility criteria: Inclusion Criteria:

1. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
2. Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3;
3. Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator;
4. Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type psoriasis;
2. History or evidence of active/latent tuberculosis;
3. Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
4. History of serious infection within 2 months before screening;
5. History of malignancy of any organ system;
6. Inadequate washout period for prior psoriatic therapy;
7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
8. Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.

Primary outcomes:
measure: Assessment of Safety
timeFrame: Baseline till Week 20
measure: PK evaluation: T1/2
timeFrame: Baseline till week 20
measure: PK evaluation: AUC
timeFrame: Baseline till week 20
measure: PK evaluation: Cmax
timeFrame: Baseline till week 20
measure: PK evaluation: Tmax
timeFrame: Baseline till week 20
Secondary outcomes:
measure: PASI 75
timeFrame: At week 12
measure: PASI 90
timeFrame: At week 12
measure: PASI 100
timeFrame: At week 12
measure: sPGA 0/1
timeFrame: At week 12
measure: Immunogenicity
timeFrame: Baseline till week 20
Other outcomes:
Locations:
city: Bengbu
country: China
facility: AkesoBio Investigative Site 1002
state: Anhui
city: Beijing
country: China
facility: AkesoBio Investigative Site 1001
Study officials:
References: