> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-study-to-evaluate-the-safety-and-efficacy-of-e9a1ae53-b554-42d5-9095-4e156681a5b9 > Record changed: 2026-11-04 # Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis NCT05509361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Participants 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Start date 2022-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Title and summary **Summary** This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Short title** Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Official title** An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Dates **Completion date** 2023-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **First posted** 2022-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Registry last updated** 2024-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Primary completion date** 2023-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Start date** 2022-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Size and sites **Actual participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Identifiers **Registry ID** NCT05509361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **ClinicalTrials.gov ID** NCT05509361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Outcomes ### Primary outcomes 1. Occurrence of Treatment-Emergent Adverse Event Timeframe: up to 52 weeks To evaluate long-term safety as assessed by occurrence of TEAE. ### Secondary outcomes 1. Occurrence of Serious Adverse Event and Adverse Events of Special Interest Timeframe: up to 52 weeks To evaluate long-term safety as assessed by occurrence of SAE and AESI. 2. Percentage of Subjects Who Achieved at least 50% (PASI 50), 75% (PASI 75) and 90% (PASI 90) Reduction in Psoriasis Area and Severity Index (PASI) Score Timeframe: up to 52 weeks 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. 3. Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1) Timeframe: up to 52 weeks 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. 4. Pharmacokinetics Assessment of AK101 Serum Concentration Timeframe: up to 52 weeks 5. Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA) Timeframe: up to 52 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection: 1. Subjects can continue to participate in this study based on assessment of investigator. 2. Subjects voluntarily participate in this study. 3. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the treatment period and for at least 6 months after the last study drug administration. - Applicable for subjects newly enrolled: 1. Male or female subjects aged ≥ 18 years old. 2. Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment. 3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3. 4. Subjects who are applicable for biological agents, based on the assessment of investigator. 5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration. Key Exclusion Criteria: - Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection: 1. Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection. 2. Subjects who used prohibited drugs in an Akeso trial with AK101 injection. 3. Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator. 4. Subjects with any other disease, abnormal physical examination or abnormal laboratory examination leading to inapplicable for participating this study, based on the assessment of investigator. - Applicable for subjects newly enrolled: 1. Forms of psoriasis other than chronic plaque-type psoriasis. 2. History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. 3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis. 4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. 5. History of prohibited psoriasis treatments within 2/4 weeks before randomization. 6. History of IL-12/23 or IL-23 inhibitors therapy. 7. Inadequate washout period of prior biological therapy. 8. History of malignant tumour within 5 years before screening. 9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Sites - Peking university people's hospitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509361) ## Related records ### Drugs (1) - [Ebdarokimab](https://trialight.com/data/asset/ebdarokimab-45f8668d-cb15-4f87-8ef8-ba945179af66.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (1) - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Primary condition ### Targets (3) - [IL12A](https://trialight.com/data/target/il12a-f7e63dfd-cd53-5ed7-ab6b-30bc302a7278.md) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. 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