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

Psoriasis Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096364
• Other study ID #: AK111-201
• Status: Completed
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Male or female, 18 to 75 years of age

2. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months

3. Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:

1. Clinical diagnosis of stable plaque psoriasis with involvement of = 10% body surface area.

2. Psoriasis area and severity index(PASI) =12.

3. Static Physicians Global Assessment score =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 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.

Key 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 according to protocol.

3. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.

4. History of a serious or systemic infection within 2 months before screening.

5. History of malignancy of any organ system within the past 5 years.

6. Inadequate washout period for prior drug 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 or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.

Locations

Country	Name	City	State
China	AkesoBio Investigative Site 1009	Beijing	Beijing
China	AkesoBio Investigative Site 1016	Beijing	Beijing
China	AkesoBio Investigative Site 1011	Bengbu	Anhui
China	AkesoBio Investigative Site 1008	Changsha	Hunan
China	AkesoBio Investigative Site 1012	Chengde	Hebei
China	AkesoBio Investigative Site 1003	Guangzhou	Guangdong
China	AkesoBio Investigative Site 1007	Guangzhou	Guangdong
China	AkesoBio Investigative Site 1018	Ha'erbin	Heilongjiang
China	AkesoBio Investigative Site 1002	Hanzhou	Zhejiang
China	AkesoBio Investigative Site 1006	Ningbo	Zhejiang
China	AkesoBio Investigative Site 1001	Shanghai	Shanghai
China	AkesoBio Investigative Site 1010	Shanghai	Shanghai
China	AkesoBio Investigative Site 1013	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12		At week 12
Secondary	Proportion of subjects who achieve PASI 75 response or higher at week 12		At week 12
Secondary	Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12		At week 12
Secondary	Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks		Baseline to week 68
Secondary	AK111 concentrations in serum at different time points		Baseline to week 68
Secondary	Number and proportion of subjects who developed anti-drug antibodies (ADAs)		Baseline to week 68
Secondary	Change in serum IL-17A level (Pharmacodynamics parameter)		Baseline to week 68
Secondary	Adverse events (AEs)/serious adverse events (SAEs)		Baseline to week 68