Clinical trial NCT06061471: To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Skin Diseases
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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. The study has 2 parts: first part (randomized double-blind) and second part (open).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: at week 16
Secondary outcomes:
measure: The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).
timeFrame: at week 16
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Nanyang
country: China
facility: Nanyang First People's hospital national third class a hospital
state: Henan
city: Yichang
country: China
facility: Yichang central People's hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Xuzhou
country: China
facility: The affiliated hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology hospital of Jiangxi province
state: Jiangxi
city: Tianjin
country: China
facility: Tianjin academy of traditional Chinese medicine affiliated hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou First People's hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The first hospital of Jiaxing
state: Zhejiang
Study officials:
References: