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

NCT05504317 | Completed Phase 1

• 1 other identifier: AK111-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• Assessment of Safety

  Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).

  Baseline till Week 20

• PK evaluation: T1/2

  Assessment of elimination half-life (T1/2) after AK111 administration.

  Baseline till week 20

• PK evaluation: AUC

  Assessment of area under curve (AUC) after AK111 administration.

  Baseline till week 20

• PK evaluation: Cmax

  Assessment of maximum plasma concentration (Cmax) after AK111 administration.

  Baseline till week 20

• PK evaluation: Tmax

  Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.

  Baseline till week 20

Secondary Outcomes (5)

• PASI 75

  At week 12

• PASI 90

  At week 12

• PASI 100

  At week 12

• sPGA 0/1

  At week 12

• Immunogenicity

  Baseline till week 20

Study Arms (2)

AK111 regimen

EXPERIMENTAL

Drug: AK111

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK111 DRUG

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

AK111 regimen

Placebo DRUG

Subjects will receive corresponding dose of placebo injection subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
• 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;
• 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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

AkesoBio Investigative Site 1002

Bengbu, Anhui, China

Location

AkesoBio Investigative Site 1001

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 36566344 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: August 17, 2022
• Study Start: May 28, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)