Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AK101 45mg every 8 weeks AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Experimental: AK101 45mg - every 12 weeks AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Experimental: AK101 90mg - every 8 weeks AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Experimental: AK101 90mg -every 12 weeks AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Experimental: AK101 135mg -every 8 weeks AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Experimental: AK101 135mg -every 12 weeks AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
|
| Placebo Comparator: Placebo to AK101 Placebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks |
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody
Biological: Placebo
matching placebo
|
Outcome Measures
Primary Outcome Measures
- Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12 [Week 12]
- 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 Outcome Measures
- Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12 [At baseline and Week 12]
- Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) [Up to Week 52 (except for Week 12)]
- Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) [Up to Week 52( except for Week 12)]
- Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12 [Up to Week 52]
- Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [Up to Week 52]
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.
- Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment [Up to Week 52]
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [Up to Week 52]
The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
- Minimum observed concentration (Cmin) of AK101 at steady state [Up to Week 52]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
-
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.
-
Candidate for systemic therapy, defined as having psoriasis inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy and/or previous systemic therapy.
-
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.
-
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
-
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Exclusion Criteria:
-
Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
-
Had other active skin diseases or skin infections (e.g., Bacterial, fungal or viral infection) that could affect psoriasis evaluation.
-
Had imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
-
History or evidence of active or latent tuberculosis at screening.
-
Serious systemic infections or local infections during the 2 months prior to screening.
-
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).
-
Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
-
Known history of alcohol or drug abuse.
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History or known presence of recurrent or chronic infection (e.g., hepatitis or C, human immunodeficiency virus [HIV], syphilis, TB).
-
Had received any DMARDs (e.g., Anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening.
-
Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening.
-
Had received any systemic psoriasis therapy (e.g., Glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening.
-
Had enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
-
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.
-
Had received natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening.
-
Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
| 2 | Peking University People's Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Akeso
- Akeso Tiancheng, Inc
Investigators
- Principal Investigator: Jianzhong Zhang, MD, Peking University People's Hospital
- Principal Investigator: Hongzhong Jin, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK101-301