A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06066125
• Other study ID #: AK111-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: October 2024

Study information

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

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Description:

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: October 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects aged =18 years old.

2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.

3. At screening and baseline, PASI score = 12 , Body Surface Area(BSA) = 10%, sPGA = 3.

4. Suitable for systematic therapy assessed by investigators.

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 during the study and for at least 6 months after the last study drug administration.

Exclusion Criteria:

1. Types of psoriasis other than chronic plaque-type psoriasis.

2. Drug-induced psoriasis.

3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.

4. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.

5. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.

6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization.

7. History of malignant tumour within 5 years before screening.

8. Previous or current autoimmune diseases.

9. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.

Related Conditions & MeSH terms

• Psoriasis
• Skin Diseases

Intervention

Drug:
• AK111
AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
• AK111
AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
• Placebo
Placebo- subcutaneous injection at week 0,1,2, 3, 4 and week 8. AK111 regimen 2-subcutaneous injection every 4 weeks from week 12 to week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

Locations

Country	Name	City	State
China	Beijing friendship hospital, Capital Medical University	Beijing
China	Peking University third hospital	Beijing
China	The first affiliated hospital of Bengbu Medical College	Bengbu	Anhui
China	The third Xiangya hospital of Central South University	Changsha	Hunan
China	West China school of medicine, West China hospital of Sichuan University	Chengdu	Sichuan
China	Affiliated hospital of Chongqing Three Gorges Medical College	Chongqing	Chongqing
China	Chongqing traditional Chinese medicine hospital (Daomenkou branch)	Chongqing	Chongqing
China	The second hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong provincial people's hospital	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The first affiliated hospital of Hainan Medical university	Haikou	Hainan
China	Hangzhou first People's hospital	Hangzhou	Zhejiang
China	Affiliated hospital of Chengde Medical University	Hebei
China	The second affiliated hospital of Harbin Medical University	Heilongjiang
China	Xiangya hospital Central South University	Hunan
China	The first hospital of Jiaxing	Jiaxing	Zhejiang
China	The frist People's hospital of Lianyungang	Lianyungang	Jiangsu
China	Dermatology hospital of Jiangxi province	Nanchang	Jiangxi
China	Dermatology Hospital of China Union Medical University	Nanjing	Jiangsu
China	Nanyang First People's hospital national third class a hospital	Nanyang	Henan
China	Ningbo Huamei hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Huashan hospital, Fudan University	Shanghai
China	Shanghai skin disease hospital	Shanghai
China	Shenzhen People's hospital	Shenzhen	Guangdong
China	Second hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tangdu hospital of the Fourth Military Medical University	Tanggu	Shanxi
China	Tianjin academy of traditional Chinese medicine affiliated hospita	Tianjin	Tianjin
China	Tianjin Medical University general hospital	Tianjin	Tianjin
China	The first affiliated hospital of wannan medical college	Wannan	Anhui
China	The first affiliated hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin hospital of Wuhan University Hubei general hospital	Wuhan	Hubei
China	The affiliated hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yancheng No.1 People's hospital	Yancheng	Jiangsu
China	Yichang central People's hospital	Yichang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12.	PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving >= 50%, >= 75% or >= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.	at week 12
Secondary	The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12.		at week 12
Secondary	The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52.		at week 52