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

NCT ID: NCT05504317

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-03-02

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..

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AK111 regimen

Group Type: EXPERIMENTAL

AK111

Intervention Type: DRUG

Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive corresponding dose of placebo injection subcutaneously.

Interventions

AK111

Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.

Intervention Type: DRUG

Placebo

Subjects will receive corresponding dose of placebo injection subcutaneously.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AkesoBio Investigative Site 1002

Bengbu, Anhui, China

AkesoBio Investigative Site 1001

Beijing, , China

Countries

China

References

Jiang C, Zhou H, Zhang W, Xia Y, Li B, Ni X, Wang G, Zhang W, Chen B, He Z, Zhang M, Chen R, Jin H, Deng L. Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):555-567. doi: 10.1007/s13555-022-00880-1. Epub 2022 Dec 24.

Reference Type: DERIVED

PMID: 36566344 (View on PubMed)

Other Identifiers

AK111-102

Identifier Type: -

Identifier Source: org_study_id