A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
NCT ID: NCT05096364
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
251 participants
INTERVENTIONAL
2021-04-28
2023-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK111 Regimen 1
AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
AK111 Regimen 2
AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
AK111 Regimen 3
AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
AK111 Regimen 4
AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks
AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Placebo to AK111
Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Interventions
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AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
3. Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
1. Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
2. Psoriasis area and severity index(PASI) ≥12.
3. Static Physicians Global Assessment score ≥3.
4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
5. Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
Exclusion Criteria
2. History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
3. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
4. History of a serious or systemic infection within 2 months before screening.
5. History of malignancy of any organ system within the past 5 years.
6. Inadequate washout period for prior drug therapy.
7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
8. Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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AkesoBio Investigative Site 1011
Bengbu, Anhui, China
AkesoBio Investigative Site 1009
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1016
Beijing, Beijing Municipality, China
AkesoBio Investigative Site 1003
Guangzhou, Guangdong, China
AkesoBio Investigative Site 1007
Guangzhou, Guangdong, China
AkesoBio Investigative Site 1012
Chengde, Hebei, China
AkesoBio Investigative Site 1018
Harbin, Heilongjiang, China
AkesoBio Investigative Site 1008
Changsha, Hunan, China
AkesoBio Investigative Site 1013
Yancheng, Jiangsu, China
AkesoBio Investigative Site 1001
Shanghai, Shanghai Municipality, China
AkesoBio Investigative Site 1010
Shanghai, Shanghai Municipality, China
AkesoBio Investigative Site 1002
Hanzhou, Zhejiang, China
AkesoBio Investigative Site 1006
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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AK111-201
Identifier Type: -
Identifier Source: org_study_id
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