A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo; Drug: AK111

• Registration Number: NCT05504317
• Lead Sponsor: Akeso

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..

Study Timeline

• Study Start: 2020-05-19
• Primary Completion: 2021-03-09
• Study Completion: 2021-03-09
• Study First Submitted: 2022-06-29
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AK111 regimen	AK111	-

Primary Outcome Measures

Name	Time	Method
PK evaluation: Tmax	Baseline till week 20	Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
PK evaluation: AUC	Baseline till week 20	Assessment of area under curve (AUC) after AK111 administration.
Assessment of Safety	Baseline till Week 20	Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
PK evaluation: T1/2	Baseline till week 20	Assessment of elimination half-life (T1/2) after AK111 administration.
PK evaluation: Cmax	Baseline till week 20	Assessment of maximum plasma concentration (Cmax) after AK111 administration.

Secondary Outcome Measures

Name	Time	Method
PASI 75	At week 12	Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 75 response which means whose PASI score decrease at least 75 percent compared with baseline at week 12.; PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
sPGA 0/1	At week 12	Proportion of subjects who achieve Static Physicians Global Assessment (sPGA) 0/1 which means whose sPGA score is clear or almost-clear at week 12.; The sPGA is a measure of global assessment of the patient's overall severity, which could be converted to numerals ranging from 0 to 5 (clear = 0, almost-clear = 1, mild = 2, moderate = 3, marked = 4, and severe = 5).
PASI 90	At week 12	Proportion of subjects who achieve PASI 90 response which means whose PASI score decrease at least 90 percent compared with baseline at week 12.; PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Immunogenicity	Baseline till week 20	Proportion of subjects with detectable anti-drug antibody (ADA).
PASI 100	At week 12	Proportion of subjects who achieve PASI 100 response which means whose PASI score decrease 100 percent compared with baseline at week 12.; PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).

Trial Locations

Locations (2)

AkesoBio Investigative Site 1002; 🇨🇳 Bengbu, Anhui, China

AkesoBio Investigative Site 1001; 🇨🇳 Beijing, China