A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

Phase 3

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: AK101; Drug: Placebo

• Registration Number: NCT05120297
• Lead Sponsor: Akeso

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2021-11-29
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

1. Male or female subjects aged ≥ 18 years.
2. Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration.

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type psoriasis.
2. History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.
6. History of IL12/23 or IL-23 inhibitors therapy.
7. Inadequate washout period of prior biological therapy.
8. History of malignant tumour within 5 years before screening.
9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK101	AK101	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.	At week 16
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).	At week 16

Secondary Outcome Measures

Name	Time	Method
PK: AK101 serum concentration at different time points after administration.	Baseline to week 16
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).	Baseline to week 16
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).	Baseline to week 16
Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit.	Baseline to week 16
Percentage change of PASI from baseline.	Baseline to week 16
Percentage of subjects who achieved sPGA 0/1 at each visit.	Baseline to week 16

Trial Locations

Locations (52)

AkesoBio Investigative Site 1010; 🇨🇳 Bengbu, Anhui, China

AkesoBio Investigative Site 1028; 🇨🇳 Hefei, Anhui, China

AkesoBio Investigative Site 1013; 🇨🇳 Wuhu, Anhui, China

AkesoBio Investigative Site 1001; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1027; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1034; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1035; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1036; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1049; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1051; 🇨🇳 Beijing, Beijing, China

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