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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04173637
Other study ID # AK101-301
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 19, 2019
Est. completion date March 3, 2022

Study information

Verified date March 2023
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date March 3, 2022
Est. primary completion date June 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Have had Plaque Psoriasis diagnosed at least 6 months prior to screening. 2. Clinical diagnosis of stable plaque psoriasis with involvement of = 10% body surface area. Psoriasis area and severity index(PASI) =12. Physicians Global Assessment score =3. 3. Candidate for systemic therapy, defined as having psoriasis inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy and/or previous systemic therapy. 4. Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last doses of study treatment. 5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol. Exclusion Criteria: 1. Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular). 2. Had other active skin diseases or skin infections (e.g., Bacterial, fungal or viral infection) that could affect psoriasis evaluation. 3. Had imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening. 4. History or evidence of active or latent tuberculosis at screening. 5. Serious systemic infections or local infections during the 2 months prior to screening. 6. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved). 7. Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study. 8. Known history of alcohol or drug abuse. 9. History or known presence of recurrent or chronic infection (e.g., hepatitis or C, human immunodeficiency virus [HIV], syphilis, TB). 10. Had received any DMARDs (e.g., Anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening. 11. Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening. 12. Had received any systemic psoriasis therapy (e.g., Glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening. 13. Had enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials. 14. Had received previous treatment with any anti-IL-12/IL-23, IL-12, IL-23, IL-17 therapy for the treatment of psoriasis or psoriatic arthritis. 15. Had received natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening. 16. Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AK101
an anti-IL-12/23p40 monoclonal antibody
Placebo
matching placebo

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Akeso Akeso Tiancheng, Inc

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who achieved = 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12 Week 12
Primary Incidence of treatment emergent adverse events (TEAEs) From the time of signing the informed consent form till last follow-up visit (Up to Week 52)
Secondary Number of participants who achieved = 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12 At baseline and Week 12
Secondary Number of participants who achieved = 75% reduction in Psoriasis Area and Severity Index (PASI75) Up to Week 52 (except for Week 12)
Secondary Number of participants who achieved = 90% reduction in Psoriasis Area and Severity Index (PASI90) Up to Week 52( except for Week 12)
Secondary Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12 Up to Week 52
Secondary Proportion of subjects who achieve a = 4-point reduction in DLQI from baseline The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall Qol, can be used to assess six different aspects that mey affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Up to Week 52
Secondary Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment Up to Week 52
Secondary Number of subjects who develop detectable anti-drug antibodies (ADAs) The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs) Up to Week 52
Secondary Minimum observed concentration (Cmin) of AK101 at steady state Up to Week 52
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