A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT04172233
Last Updated: 2025-03-03
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
PHASE1/PHASE2
96 participants
INTERVENTIONAL
2018-01-09
2019-10-31
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
DOUBLE
Study Groups
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Phase I: AK101 45 mg
Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase I: AK101 135 mg
Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase I: AK101 270 mg
Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase I: Placebo
Biological: Placebo Placebo on Week 0 and 4 by subcutaneous injection
placebo
matching placebo
Phase II: AK101 45 mg
Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase II: AK101 90 mg
Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase II: AK101 135 mg
Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Phase II: Placebo to AK101
Drug: Placebo Placebo on Week 1 and 4 by subcutaneous injection, and then AK101 on Week 12 16 by subcutaneous injection
AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
placebo
matching placebo
Interventions
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AK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
placebo
matching placebo
Eligibility Criteria
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Inclusion Criteria
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. Patients who have received systemic therapy or phototherapy, or who have been allowed by the investigator to receive systemic therapy or phototherapy.
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 dose 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
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. History of alcohol or drug abuse.
9. History or known presence of recurrent or chronic infection (e.g., hepatitis B, 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 previous treatment with 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.
18 Years
65 Years
ALL
No
Sponsors
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Akeso Tiancheng, Inc
OTHER
Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Rui Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Hongzhong Jin, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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AK101-101
Identifier Type: -
Identifier Source: org_study_id
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