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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06061471
Other study ID # AK111-203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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