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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

452

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2021

Shorter than P25 for phase_3

Geographic Reach

1 country

52 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

November 3, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed

14 days until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2022

Completed

Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

November 3, 2021

Last Update Submit

March 1, 2023

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

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 Outcomes (6)

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 of subjects who achieved sPGA 0/1 at each visit.
Baseline to week 16
Percentage change of PASI from baseline.
Baseline to week 16
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
+1 more secondary outcomes

Study Arms (2)

AK101

EXPERIMENTAL

Drug: AK101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK101DRUG

Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.

AK101

PlaceboDRUG

Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects aged ≥ 18 years.
Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 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 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.

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 had initiated and maintained according to protocol.
Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
History of prohibited psoriasis treatments within 2/4 weeks before randomization.
History of IL12/23 or IL-23 inhibitors therapy.
Inadequate washout period of prior biological therapy.
History of malignant tumour within 5 years before screening.
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Akesolead

Study Sites (52)

AkesoBio Investigative Site 1010

Bengbu, Anhui, China

Location

AkesoBio Investigative Site 1028

Hefei, Anhui, China

Location

AkesoBio Investigative Site 1013

Wuhu, Anhui, China

Location

AkesoBio Investigative Site 1001