Plaque PsoriasisPhase 2NCT04173637
Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing AK101 in people with Plaque Psoriasis, run by Akeso at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- AK101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 2 sitesChina
- Study dates
- 19 Dec 2019to 3 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Peking University People's Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
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
- Being tested
- AK101, Placebo
- Keywords
- IL12/23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK101Biological
an anti-IL-12/23p40 monoclonal antibody
PlaceboBiological
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| AK101 45mg every 8 weeks | Experimental | AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: AK101; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12
Measured: Week 12
Incidence of treatment emergent adverse events (TEAEs)
Measured: 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
Measured: At baseline and Week 12
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Measured: Up to Week 52 (except for Week 12)
Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90)
Measured: 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
Measured: Up to Week 52
Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline
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.
Measured: Up to Week 52
Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment
Measured: Up to Week 52
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)
Measured: Up to Week 52
Minimum observed concentration (Cmin) of AK101 at steady state
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start19 Dec 2019
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, MD, Principal investigator, Peking University People's HospitalHongzhong Jin, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173637
- Sponsor's protocol ID
- AK101-301
- Status last verified
- Feb 2025
- First submitted
- 19 Nov 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04173637
- Acronym / sponsor ID
- AK101-301
- Conditions
- Plaque Psoriasis
- Keywords
- IL12/23
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| AK101 45mg every 8 weeks | Experimental | Biological: AK101AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks |
| AK101 45mg - every 12 weeks | Experimental | Biological: AK101AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks |
| AK101 90mg - every 8 weeks | Experimental | Biological: AK101AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks |
| AK101 90mg -every 12 weeks | Experimental | Biological: AK101AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks |
| AK101 135mg -every 8 weeks | Experimental | Biological: AK101AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks |
| AK101 135mg -every 12 weeks | Experimental | Biological: AK101AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks |
| Placebo to AK101 | Placebo comparator | Biological: AK101, Biological: PlaceboPlacebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK101an anti-IL-12/23p40 monoclonal antibody | Biological | 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 |
| Placebomatching placebo | Biological | Placebo to AK101 |
Primary outcome
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12
Time frame: Week 12
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)
8 secondary outcomes
Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12
Time frame: At baseline and Week 12
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Time frame: Up to Week 52 (except for Week 12)
Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90)
Time frame: 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
Time frame: Up to Week 52
Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline
Time frame: Up to Week 52
Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment
Time frame: Up to Week 52
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: Up to Week 52
Minimum observed concentration (Cmin) of AK101 at steady state
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianzhong Zhang, MD principal investigator
Peking University People's Hospital
Hongzhong Jin, MD principal investigator
Peking Union Medical College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK101 in people with Plaque Psoriasis, run by Akeso at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.