Chronic Spontaneous UrticariaPhase 2NCT07875426
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
A Phase 2 study testing AK139 in people with Chronic Spontaneous Urticaria, run by Akeso.
Trial summary
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection in patients with chronic spontaneous urticaria (CSU) receiving background treatment with H1-antihistamines (H1-AHs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- AK139
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2026to 5 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF)
- Diagnosis of chronic spontaneous urticaria (CSU) for ≥6 months before the screening visit, with persistent itch and hives despite treatment with H1-antihistamines (H1-AHs) for ≥6 weeks within the year before screening.
- During the 7 days before randomization, participants must have a 7-Day Urticaria Activity Score (UAS7) ≥16 and a 7-Day Itch Severity Score (ISS7) ≥8, with an in-clinic Urticaria Activity Score (UAS) ≥4 at least one of the screening visit days or at randomization visit.
- Participants must be willing and able to complete a daily symptom electronic diary (eDiary) as required by the protocol throughout the study.
- Female participants must not be pregnant or breastfeeding. Participants and their partners must agree to use the contraceptive methods from the time of signing the informed consent form throughout the treatment period and for the period specified in the protocol after the last administration of the investigational product. Participants and their partners must also refrain from donating sperm or ova during this period.
Who cannot join
- History or current presence of inducible urticaria with a clearly identifiable trigger, or any other condition that may present with symptoms of urticaria and/or angioedema.
- Participants with any chronic pruritic skin disease other than CSU that may interfere with the evaluation of the study results.
- Participants with chronic hepatitis B, chronic hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.
- Active tuberculosis or autoimmune disease; known or suspected immunodeficiency; or a history of unusually frequent, recurrent, or prolonged infections, as determined by the investigator.
- History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC) within 6 months before screening.
- History of an inadequate response to biologic therapy for CSU, or prior treatment with an interleukin-4 (IL-4), interleukin-13 (IL-13), interleukin-4 receptor (IL-4R), or interleukin-33 (IL-33)/suppression of tumorigenicity 2 (ST2) inhibitor.
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- Prior treatment with a biologic agent without completion of the applicable washout period specified in the protocol before screening.
- Use of immunosuppressive or immunomodulatory medications within 30 days or 5 half-lives before screening, whichever is longer.
- Use of topical corticosteroids for the treatment of CSU, or oral doxepin, within 14 days before screening.
- Use of traditional Chinese medicines, including herbal or proprietary Chinese medicines intended to treat CSU, or receipt of phototherapy within 30 days before screening.
- Any other known systemic disease or laboratory abnormality that, in the investigator's judgment, may make the participant unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 Injection in Patients With Chronic Spontaneous Urticaria
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection in patients with chronic spontaneous urticaria (CSU) receiving background treatment with H1-antihistamines (H1-AHs).
Read the detailed description
This trial consists of two parts. In Part 1, participants will be randomly assigned to receive one of two prespecified dose levels of AK139. The design of Part 2, including dose selection, will be informed by the results from Part 1. In Part 2, participants will also be randomly assigned to receive one of two selected dose levels of AK139 or Placebo.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- AK139, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK139Biological
AK139 administered subcutaneously
PlaceboBiological
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| AK139 regimen 1（part1） | Experimental | AK139 regimen 1（Part1） will be administered by subcutaneous injection Receives: Biological: AK139 |
| AK139 regimen 2（part1） | Experimental | AK139 regime 2 （part1）will be administered by subcutaneous injection. Receives: Biological: AK139 |
| AK139 regimen 1（part2） | Experimental | AK139 regime 1 （part2）will be administered by subcutaneous injection. Receives: Biological: AK139 |
| AK139 regimen 2（part2） | Experimental | AK139 regime 2 （part2）will be administered by subcutaneous injection. Receives: Biological: AK139 |
| Placebo | Placebo comparator | Placebo will be administered by subcutaneous injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 7-Day Urticaria Activity Score (UAS7) .
The UAS7 is the sum of daily itch severity and hive count scores over 7 consecutive days, ranging from 0 to 42, with higher scores indicating greater disease activity.
Measured: Week 16
Secondary outcomes (18)
Change From Baseline in 7-Day Itch Severity Score (ISS7).
The ISS7 is the sum of daily itch severity scores over 7 consecutive days, ranging from 0 to 21, with higher scores indicating more severe itching.
Measured: Week 16
Change From Baseline in the 7-Day Urticaria Activity Score (UAS7)
The UAS7 is the sum of daily itch severity and hive count scores over 7 consecutive days, ranging from 0 to 42, with higher scores indicating greater disease activity; a negative change from baseline indicates improvement.
Measured: Baseline through Week 20, excluding Week 16
Change From Baseline in the 7-Day Itch Severity Score (ISS7)
The ISS7 is the sum of daily itch severity scores over 7 consecutive days, ranging from 0 to 21, with higher scores indicating more severe itching; a negative change from baseline indicates improvement.
Measured: Baseline through Week 20, excluding Week 16
Change From Baseline in the 7-Day Hives Severity Score (HSS7)
The HSS7 is the sum of daily hive severity scores over 7 consecutive days, ranging from 0 to 21, with higher scores indicating greater hive severity; a negative change from baseline indicates improvement.
Measured: Baseline through Week 20
Change From Baseline in the 7-Day Angioedema Activity Score (AAS7) in Participants With Angioedema at Baseline
The AAS7 assesses angioedema activity over 7 consecutive days and ranges from 0 to 105, with higher scores indicating greater angioedema activity; a negative change from baseline indicates improvement. This outcome will be assessed only in participants with angioedema at baseline.
Measured: Baseline through Week 20
Change From Baseline in the Urticaria Control Test (UCT) Score
The UCT is a 4-item questionnaire assessing urticaria disease control over the previous 4 weeks, with a total score ranging from 0 to 16; higher scores indicate better disease control, and a positive change from baseline indicates improvement.
Measured: Baseline and Weeks 4, 8, 12, 16, and 20
Percentage of Participants Achieving Well-Controlled Urticaria
The UCT is a 4-item questionnaire with a total score ranging from 0 to 16, with higher scores indicating better disease control. A UCT score ≥12 indicates well-controlled urticaria.
Measured: Weeks 4, 8, 12, 16, and 20
Percentage of participants with UAS7 ≤6
The UAS7 ranges from 0 to 42, with higher scores indicating greater disease activity.
Measured: Baseline through Week 20
Percentage of participants with UAS7 =0
The UAS7 ranges from 0 to 42, with higher scores indicating greater disease activity. A UAS7 score of 0 indicates a complete response, defined as the complete absence of itch and hives over 7 consecutive days.
Measured: Baseline through Week 20
Time to First UAS7 Minimal Important Difference (MID) Response During the 16-Week Treatment Period
Time to response is defined as the time from baseline to the first occurrence of a UAS7 MID response.
Measured: Baseline through Week 16
Percentage of Participants Achieving a UAS7 Minimal Important Difference (MID) Response
The MID represents the smallest change in UAS7 considered meaningful to participants and indicative of clinically relevant improvement.
Measured: Baseline through Week 20
Time to First ISS7 Minimal Important Difference (MID) Response
The MID represents the smallest change in ISS7 considered meaningful to participants and indicative of clinically relevant improvement in itch severity.
Measured: Baseline through Week 16
Percentage of Participants Achieving an ISS7 Minimal Important Difference (MID) Response
The MID represents the smallest change in ISS7 considered meaningful to participants and indicative of clinically relevant improvement in itch severity.
Measured: Baseline through Week 20
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10-item questionnaire assessing the impact of skin disease on health-related quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment; a negative change from baseline indicates improvement.
Measured: Week 16
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To evaluate the safety and tolerability of AK139
Measured: Baseline through Week 20
Pharmacokinetics (PK)
Serum concentrations of AK139 following administration.
Measured: Baseline through Week 20
Pharmacodynamics (PD)
Change from baseline in serum biomarker levels
Measured: From baseline to Week 20
Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Incidence of Anti-drug antibodies(ADA) and Neutralizing antibody (Nab) after treatment.
Measured: From baseline to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion8 Jan 2029 (estimated)
- Study completion5 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875426
- Sponsor's protocol ID
- AK139-207
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 Injection in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07875426
- Acronym / sponsor ID
- AK139-207
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 5 Feb 2029 (estimated)
- First posted
- 15 Oct 2026 (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.
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection in patients with chronic spontaneous urticaria (CSU) receiving background treatment with H1-antihistamines (H1-AHs).
Detailed description
This trial consists of two parts. In Part 1, participants will be randomly assigned to receive one of two prespecified dose levels of AK139. The design of Part 2, including dose selection, will be informed by the results from Part 1. In Part 2, participants will also be randomly assigned to receive one of two selected dose levels of AK139 or Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AK139 regimen 1（part1） | Experimental | Biological: AK139AK139 regimen 1（Part1） will be administered by subcutaneous injection |
| AK139 regimen 2（part1） | Experimental | Biological: AK139AK139 regime 2 （part1）will be administered by subcutaneous injection. |
| AK139 regimen 1（part2） | Experimental | Biological: AK139AK139 regime 1 （part2）will be administered by subcutaneous injection. |
| AK139 regimen 2（part2） | Experimental | Biological: AK139AK139 regime 2 （part2）will be administered by subcutaneous injection. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo will be administered by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF)
- Diagnosis of chronic spontaneous urticaria (CSU) for ≥6 months before the screening visit, with persistent itch and hives despite treatment with H1-antihistamines (H1-AHs) for ≥6 weeks within the year before screening.
- During the 7 days before randomization, participants must have a 7-Day Urticaria Activity Score (UAS7) ≥16 and a 7-Day Itch Severity Score (ISS7) ≥8, with an in-clinic Urticaria Activity Score (UAS) ≥4 at least one of the screening visit days or at randomization visit.
- Participants must be willing and able to complete a daily symptom electronic diary (eDiary) as required by the protocol throughout the study.
- Female participants must not be pregnant or breastfeeding. Participants and their partners must agree to use the contraceptive methods from the time of signing the informed consent form throughout the treatment period and for the period specified in the protocol after the last administration of the investigational product. Participants and their partners must also refrain from donating sperm or ova during this period.
Key exclusion criteria (11 listed)
- History or current presence of inducible urticaria with a clearly identifiable trigger, or any other condition that may present with symptoms of urticaria and/or angioedema.
- Participants with any chronic pruritic skin disease other than CSU that may interfere with the evaluation of the study results.
- Participants with chronic hepatitis B, chronic hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.
- Active tuberculosis or autoimmune disease; known or suspected immunodeficiency; or a history of unusually frequent, recurrent, or prolonged infections, as determined by the investigator.
- History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC) within 6 months before 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 |
|---|---|---|
| AK139AK139 administered subcutaneously | Biological | AK139 regimen 1（part1）, AK139 regimen 1（part2）, AK139 regimen 2（part1）, AK139 regimen 2（part2） |
| PlaceboPlacebo administered subcutaneously | Biological | Placebo |
Primary outcome
Change From Baseline in 7-Day Urticaria Activity Score (UAS7) .
Time frame: Week 16
The UAS7 is the sum of daily itch severity and hive count scores over 7 consecutive days, ranging from 0 to 42, with higher scores indicating greater disease activity.
18 secondary outcomes
Change From Baseline in 7-Day Itch Severity Score (ISS7).
Time frame: Week 16
Change From Baseline in the 7-Day Urticaria Activity Score (UAS7)
Time frame: Baseline through Week 20, excluding Week 16
Change From Baseline in the 7-Day Itch Severity Score (ISS7)
Time frame: Baseline through Week 20, excluding Week 16
Change From Baseline in the 7-Day Hives Severity Score (HSS7)
Time frame: Baseline through Week 20
Change From Baseline in the 7-Day Angioedema Activity Score (AAS7) in Participants With Angioedema at Baseline
Time frame: Baseline through Week 20
Change From Baseline in the Urticaria Control Test (UCT) Score
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Percentage of Participants Achieving Well-Controlled Urticaria
Time frame: Weeks 4, 8, 12, 16, and 20
Percentage of participants with UAS7 ≤6
Time frame: Baseline through Week 20
Percentage of participants with UAS7 =0
Time frame: Baseline through Week 20
Time to First UAS7 Minimal Important Difference (MID) Response During the 16-Week Treatment Period
Time frame: Baseline through Week 16
Percentage of Participants Achieving a UAS7 Minimal Important Difference (MID) Response
Time frame: Baseline through Week 20
Time to First ISS7 Minimal Important Difference (MID) Response
Time frame: Baseline through Week 16
Percentage of Participants Achieving an ISS7 Minimal Important Difference (MID) Response
Time frame: Baseline through Week 20
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score
Time frame: Week 16
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Baseline through Week 20
Pharmacokinetics (PK)
Time frame: Baseline through Week 20
Pharmacodynamics (PD)
Time frame: From baseline to Week 20
Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Time frame: From baseline to Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK139 in people with Chronic Spontaneous Urticaria, run by Akeso.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqin Wang (+86 (0760) 8987 399, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 7-Day Urticaria Activity Score (UAS7) . (time frame: Week 16). 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 15 Oct 2026.