To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT06061471
- Lead Sponsor
- Akeso
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 454
- Male or female subjects aged ≥18 years old.
- Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
- At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3.
- Suitable for systematic therapy assessed by investigators.
- 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.
- Types of psoriasis other than chronic plaque-type psoriasis.
- Drug-induced psoriasis.
- Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
- Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological,hematological, endocrine and other systems before randomization.
- History of malignant tumour within 5 years before screening.
- Previous or current autoimmune diseases.
- Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: AK111 regimen 1 AK111 - Experimental: AK111 regimen 2 AK111 -
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90). at week 16
Trial Locations
- Locations (11)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, Hebei, China
Nanyang First People's hospital national third class a hospital
🇨🇳Nanyang, Henan, China
Yichang central People's hospital
🇨🇳Yichang, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The affiliated hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Dermatology hospital of Jiangxi province
🇨🇳Nanchang, Jiangxi, China
Tianjin academy of traditional Chinese medicine affiliated hospital
🇨🇳Tianjin, Tianjin, China
Hangzhou First People's hospital
🇨🇳Hangzhou, Zhejiang, China
The first hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China