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

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: AK111; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • AkesoBio Investigative Site 1001
  • Anhui
    • Bengbu, Anhui, China
      • AkesoBio Investigative Site 1002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subjects will receive corresponding dose of placebo injection subcutaneously.
Experimental: AK111 regimen	Drug: AK111; Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI 75	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).	At week 12
PASI 90	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).	At week 12
PASI 100	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).	At week 12
sPGA 0/1	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).	At week 12
Immunogenicity	Proportion of subjects with detectable anti-drug antibody (ADA).	Baseline till week 20

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: AK111-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No