A Phase 2 interventional study of AK139 and Placebo in Chronic Spontaneous Urticaria, sponsored by Akeso. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Akeso · Phase 2, Interventional, and Treatment
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).
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.
216 studies on the registry are indexed under Chronic Urticaria; 47 are open to participants now.
This study's planned enrollment of 201 is above the median of 83 across 165 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Akeso is the lead sponsor of 156 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
AK139 regimen 1（Part1） will be administered by subcutaneous injection
Biological: AK139
AK139 regime 2 （part1）will be administered by subcutaneous injection.
Biological: AK139
AK139 regime 1 （part2）will be administered by subcutaneous injection.
Biological: AK139
AK139 regime 2 （part2）will be administered by subcutaneous injection.
Biological: AK139
Placebo will be administered by subcutaneous injection.
Biological: Placebo
AK139 administered subcutaneously
Placebo administered subcutaneously
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.
Time frame: Week 16
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 16
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To evaluate the safety and tolerability of AK139
Time frame: Baseline through Week 20
Pharmacokinetics (PK)
Serum concentrations of AK139 following administration.
Time frame: Baseline through Week 20
Pharmacodynamics (PD)
Change from baseline in serum biomarker levels
Time frame: 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.
Time frame: From baseline to Week 20
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: AK139