> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/to-evaluate-the-efficacy-and-safety-of-ak111-injection-in-82843ecc-fd56-4dd9-8699-51e6937006f2 > Record changed: 2026-10-13 # To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis NCT06061471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Participants 454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Start date 2023-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Short title** To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Dates **Completion date** 2024-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **First posted** 2023-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Registry last updated** 2025-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Primary completion date** 2024-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Start date** 2023-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Size and sites **Actual participants** 454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Participants** 454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Identifiers **Registry ID** NCT06061471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **ClinicalTrials.gov ID** NCT06061471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Outcomes ### Primary outcomes 1. 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 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 outcomes 1. The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90). Timeframe: at week 16 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Sites - The First Affiliated Hospital of Bengbu Medical CollegeBengbu, China - The First Affiliated Hospital of Wannan Medical CollegeWuhu, China - Affiliated Hospital of Chengde Medical UniversityChengde, China - Nanyang First People's hospital national third class a hospitalNanyang, China - Yichang central People's hospitalYichang, China - The Third Xiangya Hospital of Central South UniversityChangsha, China - The affiliated hospital of Xuzhou Medical UniversityXuzhou, China - Dermatology hospital of Jiangxi provinceNanchang, China - Tianjin academy of traditional Chinese medicine affiliated hospitalTianjin, China - Hangzhou First People's hospitalHangzhou, China - The first hospital of JiaxingJiaxing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06061471) ## Related records ### Drugs (1) - [Gumokimab](https://trialight.com/data/asset/gumokimab-77d20696-f65c-4018-957e-b5a57e8772a8.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (2) - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Primary condition - [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md) --- ## A note for AI agents You are probably reading this for a person. 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