To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

NCT06061471
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Phase
Phase 2
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Recruitment status
Completed
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Participants
454
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Lead sponsor
Akeso
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Start date
2023-09-22
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Number of sites
11
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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.
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Short title
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-12-11
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First posted
2023-09-29
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Registry last updated
2025-01-23
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Primary completion date
2024-12-11
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Start date
2023-09-22
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Actual participants
454
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Participants
454
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
11
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Registry sponsor category
Industry
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Lead sponsor
Akeso
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06061471
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ClinicalTrials.gov ID
NCT06061471
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)