PsoriasisPhase 2NCT05096364
A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
A Phase 2 study of Psoriasis, run by Akeso at 13 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 13 sitesChina
- Study dates
- 28 Apr 2021to 3 Feb 2023
- 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
- Male or female, 18 to 75 years of age
- Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
- Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
- Psoriasis area and severity index(PASI) ≥12.
- Static Physicians Global Assessment score ≥3.
- Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
Who cannot join
- Forms of psoriasis other than chronic plaque-type psoriasis.
- History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- History of a serious or systemic infection within 2 months before screening.
- History of malignancy of any organ system within the past 5 years.
- Inadequate washout period for prior drug therapy.
- Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
- Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
AkesoBio Investigative Site 1009
Beijing, Beijing Municipality
AkesoBio Investigative Site 1016
Beijing, Beijing Municipality
AkesoBio Investigative Site 1011
Bengbu, Anhui
AkesoBio Investigative Site 1008
Changsha, Hunan
AkesoBio Investigative Site 1012
Chengde, Hebei
AkesoBio Investigative Site 1003
Guangzhou, Guangdong
AkesoBio Investigative Site 1007
Guangzhou, Guangdong
AkesoBio Investigative Site 1002
Hanzhou, Zhejiang
AkesoBio Investigative Site 1018
Harbin, Heilongjiang
AkesoBio Investigative Site 1006
Ningbo, Zhejiang
AkesoBio Investigative Site 1001
Shanghai, Shanghai Municipality
AkesoBio Investigative Site 1010
Shanghai, Shanghai Municipality
AkesoBio Investigative Site 1013
Yancheng, Jiangsu
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
- Conditions
- Psoriasis
- Being tested
- AK111/Placebo
- Keywords
- AK111, efficacy, safety
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK111/PlaceboBiological
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AK111 Regimen 1 | Experimental | AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks Receives: Biological: AK111/Placebo |
| AK111 Regimen 2 | Experimental | AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks Receives: Biological: AK111/Placebo |
| AK111 Regimen 3 | Experimental | AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks Receives: Biological: AK111/Placebo |
| AK111 Regimen 4 | Experimental | AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks Receives: Biological: AK111/Placebo |
| Placebo to AK111 | Placebo comparator | Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12 Receives: Biological: AK111/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Measured: At week 12
Secondary outcomes (7)
Proportion of subjects who achieve PASI 75 response or higher at week 12
Measured: At week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Measured: At week 12
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
Measured: Baseline to week 68
AK111 concentrations in serum at different time points
Measured: Baseline to week 68
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Measured: Baseline to week 68
Change in serum IL-17A level (Pharmacodynamics parameter）
Measured: Baseline to week 68
Adverse events (AEs)/serious adverse events (SAEs)
Measured: Baseline to week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start28 Apr 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096364
- Sponsor's protocol ID
- AK111-201
- Status last verified
- Feb 2025
- First submitted
- 15 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05096364
- Acronym / sponsor ID
- AK111-201
- Conditions
- Psoriasis
- Keywords
- AK111, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 27 Oct 2021 (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 randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AK111 Regimen 1 | Experimental | Biological: AK111/PlaceboAK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks |
| AK111 Regimen 2 | Experimental | Biological: AK111/PlaceboAK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks |
| AK111 Regimen 3 | Experimental | Biological: AK111/PlaceboAK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks |
| AK111 Regimen 4 | Experimental | Biological: AK111/PlaceboAK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks |
| Placebo to AK111 | Placebo comparator | Biological: AK111/PlaceboPlacebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 to 75 years of age
- Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
- Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
- Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
Key exclusion criteria (8 listed)
- Forms of psoriasis other than chronic plaque-type psoriasis.
- History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- History of a serious or systemic infection within 2 months before screening.
- History of malignancy of any organ system within the past 5 years.
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 |
|---|---|---|
| AK111/PlaceboAfter loading dose, investigational drug was administered subcutaneously up to 60 weeks. | Biological | AK111 Regimen 1, AK111 Regimen 2, AK111 Regimen 3, AK111 Regimen 4, Placebo to AK111 |
Primary outcome
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time frame: At week 12
7 secondary outcomes
Proportion of subjects who achieve PASI 75 response or higher at week 12
Time frame: At week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Time frame: At week 12
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
Time frame: Baseline to week 68
AK111 concentrations in serum at different time points
Time frame: Baseline to week 68
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Time frame: Baseline to week 68
Change in serum IL-17A level (Pharmacodynamics parameter）
Time frame: Baseline to week 68
Adverse events (AEs)/serious adverse events (SAEs)
Time frame: Baseline to week 68
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Psoriasis, run by Akeso at 13 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 8 inclusion and 8 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 13 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?
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12 (time frame: At week 12). 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.