To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Phase II 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: Recruiting

Administrative data

• NCT number: NCT06061471
• Other study ID #: AK111-203
• Status: Recruiting
• Phase: Phase 2
• Start date: September 14, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Akeso
• Contact: Wang Guoqin
• Phone: +86 (0760) 8987 3999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind phase II 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 phase II 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 regimen 1 or regimen 2 subcutaneous injection and follow up to week 32.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• 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 with moderate to severe plaque psoriasis with or without psoriatic arthritis.

3. At screening and baseline, PASI score = 12, BSA = 10%, sPGA = 3.

4. Suitable for systematic therapy assessed by investigators.

5. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational 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,until week 24.
• AK111
AK111 regimen 2-subcutaneous injection,until week 24.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Affiliated Hospital of Chengde Medical University	Chengde	Hebei
China	Hangzhou First People's hospital	Hangzhou	Zhejiang
China	The first hospital of Jiaxing	Jiaxing	Zhejiang
China	Dermatology hospital of Jiangxi province	Nanchang	Jiangxi
China	Nanyang First People's hospital national third class a hospital	Nanyang	Henan
China	Tianjin academy of traditional Chinese medicine affiliated hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	The affiliated hospital of Xuzhou Medical University	Xuzhou	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 Severity Index (PASI)score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.	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 16
Secondary	The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).		at week 16