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

NCT04172233 | Completed Phase 1

• 1 other identifier: AK101-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis.

Conditions

Plaque Psoriasis

Keywords

IL12/23

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAEs)

  From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II

Secondary Outcomes (7)

• Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)

  At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)

• Number of participants who achieved ≥ 90% reduction in PASI (PASI90)

  At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)

• Change From Baseline in the Physician Global Assessment (PGA)

  At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From first dose till Week 16 for Phase I or Week 28 for Phase II

• Area under the curve (AUC) of AK101

  From first dose till Week 16 for Phase I

Study Arms (8)

Phase I: AK101 45 mg

EXPERIMENTAL

Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection

Biological: AK101

Phase I: AK101 135 mg

EXPERIMENTAL

Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection

Biological: AK101

Phase I: AK101 270 mg

EXPERIMENTAL

Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection

Biological: AK101

Phase I: Placebo

PLACEBO COMPARATOR

Biological: Placebo Placebo on Week 0 and 4 by subcutaneous injection

Biological: placebo

Phase II: AK101 45 mg

EXPERIMENTAL

Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection

Biological: AK101

Phase II: AK101 90 mg

EXPERIMENTAL

Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection

Biological: AK101

Phase II: AK101 135 mg

EXPERIMENTAL

Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection

Biological: AK101

Phase II: Placebo to AK101

PLACEBO COMPARATOR

Drug: Placebo Placebo on Week 1 and 4 by subcutaneous injection, and then AK101 on Week 12 16 by subcutaneous injection

Biological: AK101; Biological: placebo

Interventions

AK101 BIOLOGICAL

AK101 is an anti-IL-12/23p40 monoclonal antibody.

Phase I: AK101 135 mg; Phase I: AK101 270 mg; Phase I: AK101 45 mg; Phase II: AK101 135 mg; Phase II: AK101 45 mg; Phase II: AK101 90 mg; Phase II: Placebo to AK101

placebo BIOLOGICAL

matching placebo

Phase I: Placebo; Phase II: Placebo to AK101

Eligibility Criteria

• Age: 18 Years - 65 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.
• Patients who have received systemic therapy or phototherapy, or who have been allowed by the investigator to receive systemic therapy or phototherapy.
• 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.
• 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.
• History of alcohol or drug abuse.
• History or known presence of recurrent or chronic infection (e.g., hepatitis B, 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 previous treatment with 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 (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Officials

• Rui Chen, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Hongzhong Jin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 9, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)