CompletedNCT04172233Updated Mar 3, 2025

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

A Phase 1/2 interventional study of AK101 and placebo in Plaque Psoriasis, sponsored by Akeso. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Akeso · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Registered 1 year 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2019).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..

Conditions studied

Plaque Psoriasis

Browse trials for

Psoriasis 1,899

Keywords

IL12/23

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 96 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.
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.

Exclusion criteria

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.
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.
Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 96 participants (actual)

Study arms

Experimental
Phase I: AK101 45 mg
Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection
Biological: AK101
Experimental
Phase I: AK101 135 mg
Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection
Biological: AK101
Experimental
Phase I: AK101 270 mg
Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection
Biological: AK101
Placebo comparator
Phase I: Placebo
Biological: Placebo Placebo on Week 0 and 4 by subcutaneous injection
Biological: placebo
Experimental
Phase II: AK101 45 mg
Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection
Biological: AK101
Experimental
Phase II: AK101 90 mg
Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection
Biological: AK101
Experimental
Phase II: AK101 135 mg
Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection
Biological: AK101
Placebo comparator
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
Biological: AK101 · Biological: placebo

Interventions

BiologicalAK101
AK101 is an anti-IL-12/23p40 monoclonal antibody.
Biologicalplacebo
matching placebo

What researchers measure

Primary outcomes

Incidence of treatment emergent adverse events (TEAEs)
Time frame: From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II

Secondary outcomes

Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Time frame: 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)
Time frame: 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)
Time frame: 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)
The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
Area under the curve (AUC) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I
Minimum observed concentration (Cmin) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
Maximum observed concentration (Cmax) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II

Study locations

1 site

Peking Union Medical College Hospital
Beijing, Beijing 100730, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04172233
Lead sponsor: Akeso
Collaborators: Akeso Tiancheng, Inc
Responsible party: Sponsor
First posted: Nov 21, 2019
Start date: Jan 9, 2018
Primary completion: Oct 31, 2019
Completion: Oct 31, 2019
Last update: Mar 3, 2025

Study contacts

Rui Chen, MD

principal investigator · Peking Union Medical College Hospital

Hongzhong Jin, MD

principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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