AsthmaPhase 2NCT05155020
A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
A Phase 2 study testing AK120 in people with Asthma, run by Akeso at 19 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- AK120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 19 sitesChina
- Study dates
- 11 Feb 2022to 5 Aug 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
- Male or female subjects aged ≥18 years old and ≤75 years old;
- Asthma was diagnosed ≥ 12 months before screening, current stable treatment with medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers ≥ 3 months;
- Blood eosinophil≥ 200 cells per microliter within 6 months before screening;
- During the screening, 40% of the predicted normal value < pre-bronchodilator FEV1 < 80% of the predicted normal value, within 12 months before randomization, reversible airflow restriction was recorded;
- Asthma was inadequately controlled;
- For women with childbearing potential, they are not pregnant or lactating, and the subjects and their partners voluntarily take effective contraceptive measures judged by the investigators during the treatment and at least 3 months after last dose.
Who cannot join
- Subjects with lung diseases other than asthma, which may affect the subject's health or end point evaluation of the study;
- Subjects had severe exacerbation events or systemic glucocorticoids usage within 1 month before randomization;
- Respiratory tract infection and any serious infection within 1 month before randomization;
- Subjects with parasitic infection, active tuberculosis infection, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis positive confirmation test;
- Known or suspected history of immunosuppression;
- History of malignant tumors;
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- A history of smoking: those who had quit smoking for ≤ 6 months before screening, or smoking history > 10 pack per year;
- Previous treatment with interleukin-4 (IL-4) or interleukin-13 (IL-13) inhibitors, and inadequate washout period of other biologic therapy;
- Allergen immunotherapy within 3 months before randomization;
- Progressive or uncontrolled other diseases or any other conditions or abnormal laboratory tests for which the investigator assess that the subjects are not suitable to enrol in the study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Baogang Hospital, Inner Mongolia, China
Baotou, Inner Mongolia
Beijing Jingmei General Hospital
Beijing, Beijing Municipality
Cangzhou People's Hospital
Cangzhou, Hebei
Jilin Province People's Hospital
Changchun, Jilin
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital Zhejiang University School of Medicine,
Hangzhou, Zhejiang
The Second Hospital of Anhui Medical University
Hefei, Anhui
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia
Luoyang Central Hospital
Luoyang, Henan
Jiangxi Provincial Prople's Hospita
Nanchang, Jiangxi
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi
Shanghai General Hospital
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study. The purpose of this study is to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma and not adequately controlled with current stable medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers.Subjects will be randomized to receive AK120 or placebo subcutaneous injection.
- Conditions
- Asthma
- Being tested
- AK120, Placebo
- Keywords
- AK120, Efficacy, Safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK120Biological
AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
AK120Biological
AK120 regimen 2(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
AK120Biological
AK120 regimen 3(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
PlaceboBiological
Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.
| Study group | Role | What they receive |
|---|---|---|
| AK120 regimen 1 | Experimental | Not described Receives: Biological: AK120 |
| AK120 regimen 2 | Experimental | Not described Receives: Biological: AK120 |
| AK120 regimen 3 | Experimental | Not described Receives: Biological: AK120 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
Measured: At week 12
Secondary outcomes (11)
Annualized rate of severe exacerbation events within 24 weeks.
Measured: Baseline to Week24
Annualized rate of severe exacerbation events within 32 weeks.
Measured: Baseline to Week32
Change in pre-bronchodilator FEV1 from baseline to week 32.
Measured: Baseline to Week32
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Measured: Baseline to Week32
Change in post-bronchodilator FEV1 from baseline to week 32.
Measured: Baseline to Week32
Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
Measured: Baseline to Week32
Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
Measured: Baseline to Week32
Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
Measured: at week 12,week 24
Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
Measured: Baseline to Week32
Pharmacokinetics (PK): AK120 concentration at different time points.
Measured: Baseline to Week32
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).
Measured: Baseline to Week32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start11 Feb 2022
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Why it stopped: The clinical development strategy has been changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155020
- Sponsor's protocol ID
- AK120-201
- Status last verified
- Oct 2022
- First submitted
- 1 Dec 2021
- Last updated
- 12 Oct 2022
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
- ClinicalTrials.gov ID
- NCT05155020
- Acronym / sponsor ID
- AK120-201
- Conditions
- Asthma
- Keywords
- AK120, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical development strategy has been changed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 13 Dec 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, multicenter, phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study. The purpose of this study is to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma and not adequately controlled with current stable medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers.Subjects will be randomized to receive AK120 or placebo subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AK120 regimen 1 | Experimental | Biological: AK120 |
| AK120 regimen 2 | Experimental | Biological: AK120 |
| AK120 regimen 3 | Experimental | Biological: AK120 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged ≥18 years old and ≤75 years old;
- Asthma was diagnosed ≥ 12 months before screening, current stable treatment with medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers ≥ 3 months;
- Blood eosinophil≥ 200 cells per microliter within 6 months before screening;
- During the screening, 40% of the predicted normal value < pre-bronchodilator FEV1 < 80% of the predicted normal value, within 12 months before randomization, reversible airflow restriction was recorded;
- Asthma was inadequately controlled;
Key exclusion criteria (10 listed)
- Subjects with lung diseases other than asthma, which may affect the subject's health or end point evaluation of the study;
- Subjects had severe exacerbation events or systemic glucocorticoids usage within 1 month before randomization;
- Respiratory tract infection and any serious infection within 1 month before randomization;
- Subjects with parasitic infection, active tuberculosis infection, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis positive confirmation test;
- Known or suspected history of immunosuppression;
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 |
|---|---|---|
| AK120AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32. | Biological | AK120 regimen 1 |
| AK120AK120 regimen 2(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32. | Biological | AK120 regimen 2 |
| AK120AK120 regimen 3(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32. | Biological | AK120 regimen 3 |
| PlaceboPlacebo subcutaneous injection every two weeks up to week 24, and follow up to week 32. | Biological | Placebo |
Primary outcome
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
Time frame: At week 12
11 secondary outcomes
Annualized rate of severe exacerbation events within 24 weeks.
Time frame: Baseline to Week24
Annualized rate of severe exacerbation events within 32 weeks.
Time frame: Baseline to Week32
Change in pre-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Change in post-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
Time frame: Baseline to Week32
Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
Time frame: Baseline to Week32
Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
Time frame: at week 12,week 24
Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
Time frame: Baseline to Week32
Pharmacokinetics (PK): AK120 concentration at different time points.
Time frame: Baseline to Week32
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).
Time frame: Baseline to Week32
Results and safety
The study was stopped early (reason given: The clinical development strategy has been changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- 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.
19 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 AK120 in people with Asthma, run by Akeso at 19 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 10 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: stopped early, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 was stopped early (reason given: The clinical development strategy has been changed). Results are not available in the source record.
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?
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline 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 12 Oct 2022.