Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

NCT04173637 | Completed Phase 2 DMC

• 1 other identifier: AK101-301
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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).

Conditions

Plaque Psoriasis

Keywords

IL12/23

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (7)

AK101 45mg every 8 weeks

EXPERIMENTAL

AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks

Biological: AK101

AK101 45mg - every 12 weeks

EXPERIMENTAL

AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks

Biological: AK101

AK101 90mg - every 8 weeks

EXPERIMENTAL

AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks

Biological: AK101

AK101 90mg -every 12 weeks

EXPERIMENTAL

AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks

Biological: AK101

AK101 135mg -every 8 weeks

EXPERIMENTAL

AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks

Biological: AK101

AK101 135mg -every 12 weeks

EXPERIMENTAL

AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks

Biological: AK101

Placebo to AK101

PLACEBO COMPARATOR

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; Biological: Placebo

Interventions

AK101 BIOLOGICAL

an anti-IL-12/23p40 monoclonal antibody

AK101 135mg -every 12 weeks; AK101 135mg -every 8 weeks; AK101 45mg - every 12 weeks; AK101 45mg every 8 weeks; AK101 90mg - every 8 weeks; AK101 90mg -every 12 weeks; Placebo to AK101

Placebo BIOLOGICAL

matching placebo

Placebo to AK101

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Akeso: lead
• Akeso Tiancheng, Inc: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

• Jianzhong Zhang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Hongzhong Jin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start: December 19, 2019
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)