A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

NCT05096364 | Completed Phase 2

• 1 other identifier: AK111-201
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 13

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

AK111; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12

  At week 12

Secondary Outcomes (7)

• Proportion of subjects who achieve PASI 75 response or higher at week 12

  At week 12

• Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12

  At week 12

• Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks

  Baseline to week 68

• AK111 concentrations in serum at different time points

  Baseline to week 68

• Number and proportion of subjects who developed anti-drug antibodies (ADAs)

  Baseline to week 68

Study Arms (5)

AK111 Regimen 1

EXPERIMENTAL

AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks

Biological: AK111/Placebo

AK111 Regimen 2

EXPERIMENTAL

AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks

Biological: AK111/Placebo

AK111 Regimen 3

EXPERIMENTAL

AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks

Biological: AK111/Placebo

AK111 Regimen 4

EXPERIMENTAL

AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks

Biological: AK111/Placebo

Placebo to AK111

PLACEBO COMPARATOR

Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12

Biological: AK111/Placebo

Interventions

AK111/Placebo BIOLOGICAL

After loading dose, investigational drug was administered subcutaneously up to 60 weeks.

AK111 Regimen 1; AK111 Regimen 2; AK111 Regimen 3; AK111 Regimen 4; Placebo to AK111

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 75 years of age
• Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
• Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
• Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
• Psoriasis area and severity index(PASI) ≥12.
• Static Physicians Global Assessment score ≥3.
• Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
• Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type psoriasis.
• History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
• Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
• History of a serious or systemic infection within 2 months before screening.
• History of malignancy of any organ system within the past 5 years.
• Inadequate washout period for prior drug 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 or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Sponsors & Collaborators

• Akeso: lead

Study Sites (13)

AkesoBio Investigative Site 1011

Bengbu, Anhui, China

Location

AkesoBio Investigative Site 1009

Beijing, Beijing Municipality, China

Location

AkesoBio Investigative Site 1016

Beijing, Beijing Municipality, China

Location

AkesoBio Investigative Site 1003

Guangzhou, Guangdong, China

Location

AkesoBio Investigative Site 1007

Guangzhou, Guangdong, China

Location

AkesoBio Investigative Site 1012

Chengde, Hebei, China

Location

AkesoBio Investigative Site 1018

Harbin, Heilongjiang, China

Location

AkesoBio Investigative Site 1008

Changsha, Hunan, China

Location

AkesoBio Investigative Site 1013

Yancheng, Jiangsu, China

Location

AkesoBio Investigative Site 1001

Shanghai, Shanghai Municipality, China

Location

AkesoBio Investigative Site 1010

Shanghai, Shanghai Municipality, China

Location

AkesoBio Investigative Site 1002

Hanzhou, Zhejiang, China

Location

AkesoBio Investigative Site 1006

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 15, 2021
• First Posted: October 27, 2021
• Study Start: April 28, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)