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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504317
• Other study ID #: AK111-102
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2020
• Est. completion date: March 9, 2021

Study information

• Verified date: August 2022
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• AK111
Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.
• Placebo
Subjects will receive corresponding dose of placebo injection subcutaneously.

Locations

Country	Name	City	State
China	AkesoBio Investigative Site 1001	Beijing
China	AkesoBio Investigative Site 1002	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Safety	Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).	Baseline till Week 20
Primary	PK evaluation: T1/2	Assessment of elimination half-life (T1/2) after AK111 administration.	Baseline till week 20
Primary	PK evaluation: AUC	Assessment of area under curve (AUC) after AK111 administration.	Baseline till week 20
Primary	PK evaluation: Cmax	Assessment of maximum plasma concentration (Cmax) after AK111 administration.	Baseline till week 20
Primary	PK evaluation: Tmax	Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.	Baseline till week 20
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Immunogenicity	Proportion of subjects with detectable anti-drug antibody (ADA).	Baseline till week 20