A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- AK101
- Conditions
- Plaque Psoriasis
- Sponsor
- Akeso
- Enrollment
- 330
- Locations
- 2
- Primary Endpoint
- Incidence of treatment emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility 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) ≥
- •Physicians Global Assessment score ≥
- •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.
- •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.
Arms & Interventions
AK101 90mg - every 8 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks
Intervention: AK101
AK101 90mg -every 12 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks
Intervention: AK101
AK101 45mg every 8 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks
Intervention: AK101
AK101 45mg - every 12 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks
Intervention: AK101
AK101 135mg -every 8 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks
Intervention: AK101
AK101 135mg -every 12 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks
Intervention: AK101
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
Intervention: AK101
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
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: From the time of signing the informed consent form till last follow-up visit (Up to Week 52)
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12
Time Frame: Week 12
Secondary Outcomes
- 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 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12(Up to Week 52)
- Minimum observed concentration (Cmin) of AK101 at steady state(Up to Week 52)
- Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)(Up to Week 52 (except for Week 12))
- Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline(Up to Week 52)
- 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 participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90)(Up to Week 52( except for Week 12))
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(Up to Week 52)