Allergic DiseasesPhase 2CLEARNCT07415551
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
A Phase 2 study testing Lesigercept in people with Allergic Diseases and Chronic Spontaneous Urticaria (CSU), run by Yuhan Corporation at 30 sites in 4 countries.
Trial summary
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Diseases, Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- Lesigercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 26 Mar 2026to 24 Jul 2027
- 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
- Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).
- Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.
- Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.
- ≥80% adherence to antihistamines during screening.
Who cannot join
- Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.
- Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.
- History of malignancy within 5 years (except certain cured skin/cervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases).
- Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes.
- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.
Trial locations and contacts
30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 4 countries
Poland12 sites, 12 recruiting
- Not yet recruiting
Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko
Bialystok, Podlaskie Voivodeship, 15-010
- Not yet recruiting
Bio Zdrowie sp. z o.o.
Bialystok, Podlaskie Voivodeship, 15-698
- Not yet recruiting
NZOZ GynCentrum Oddział Libero
Katowice, Silesian Voivodeship, 40-600
- Not yet recruiting
Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)
Katowice, Silesian Voivodeship, 40-611
- Not yet recruiting
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033
- Not yet recruiting
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-011
- Not yet recruiting
Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny
Lublin, Lublin Voivodeship, 20-573
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opolskie Voivodeship, 45-401
- Not yet recruiting
Alergologia Plus Sp. z o. o.
Poznan, Greater Poland Voivodeship, 60-693
- Not yet recruiting
Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100
- Not yet recruiting
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, Lower Silesian Voivodeship, 53-201
- Not yet recruiting
DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne
Wroclaw, Lower Silesian Voivodeship, 53-613
South Korea12 sites, 12 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601
- Not yet recruiting
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, 13620
- Not yet recruiting
Korea University Ansan Hospital
Gyeonggi-do, Danwon-gu, 15355
- Not yet recruiting
Ajou University Hospital
Gyeonggi-do, Suwon, 16499
- Not yet recruiting
Inha University Hospital
Incheon, Incheon, 22332
- Recruiting
Chung-Ang University Hospital
Seoul, Dongjak-gu, 06973
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Seocho-gu, 06591
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722
- Not yet recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, 05278
- Not yet recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul, 07441
- Not yet recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
- Not yet recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Bulgaria4 sites, 4 recruiting
- Not yet recruiting
Diagnostic & Consultative Centre Ascendent EOOD
Sofia, Sofia, 1202
- Not yet recruiting
UMHAT "Aleksandrovska"
Sofia, Sofia, 1431
- Not yet recruiting
Medical Center Hera EOOD
Sofia, Sofia, 1510
- Not yet recruiting
UMHATEM "N. I. Pirogov"
Sofia, Sofia, 1606
China2 sites, 2 recruiting
- Not yet recruiting
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
Guangzhou, Guangdong, 510000
- Not yet recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.
Read the detailed description
A total of 150 participants will be randomized in a 2:1 ratio to either the lesigercept or placebo group. The study will proceed with a 12-week treatment period, during which the IP will be administered every 4 weeks for a total of three doses, followed by a 4-week follow-up. In total, participants will be observed for 16 weeks to evaluate efficacy, safety, PK, PD, and immunogenicity.
- Being tested
- Lesigercept, Placebo
- Keywords
- CSU, YH35324, Allergic disease, Chronic Spontaneous Urticaria, Yuhan, GI-301, Lesigercept, M9010
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LesigerceptDrug
Subcutaneous injection of Lesigercept
PlaceboDrug
Subcutaneous injection of None of active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Lesigercept | Experimental | * A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.
* Active Dose, Q4W Receives: Drug: Lesigercept |
| Placebo | Placebo comparator | * A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.
* Q4W Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Measured: From first dose to Week 12
Secondary outcomes (5)
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Measured: From first dose to Week 12
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Measured: From first dose to Week 12
Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12
Angioedema Activity Score over 7 days (AAS7) - minimum value: 0 / maximum value: 105 - Higher scores indicate higher disease activity (worse outcome).
Measured: From first dose to Week 12
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12
Dermatology Life Quality Index(DLQI)- minimum value: 0 / maximum value: 30 - Higher scores indicate greater impairment of quality of life (worse outcome).
Measured: From first dose to Week 12
Occurrence and severity of adverse events (AEs)
- Safety endpoints will be included but not be limited to:
- Occurrence of treatment emergent adverse events during the study
- Occurrence of treatment emergent serious adverse events during the study
Measured: Through study completion, approximately 113days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Mar 2026
- Primary completion19 Jun 2027 (estimated)
- Study completion24 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415551
- Sponsor's protocol ID
- YH35324-201
- Acronym
- CLEAR
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to jieon.lee@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)
- ClinicalTrials.gov ID
- NCT07415551
- Acronym / sponsor ID
- CLEAR / YH35324-201
- Keywords
- CSU, YH35324, Allergic disease, Chronic Spontaneous Urticaria, Yuhan, GI-301, Lesigercept, M9010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 24 Jul 2027 (estimated)
- First posted
- 17 Feb 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.
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.
Detailed description
A total of 150 participants will be randomized in a 2:1 ratio to either the lesigercept or placebo group. The study will proceed with a 12-week treatment period, during which the IP will be administered every 4 weeks for a total of three doses, followed by a 4-week follow-up. In total, participants will be observed for 16 weeks to evaluate efficacy, safety, PK, PD, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lesigercept | Experimental | Drug: Lesigercept* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Active Dose, Q4W |
| Placebo | Placebo comparator | Drug: Placebo* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Q4W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).
- Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.
- Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.
- ≥80% adherence to antihistamines during screening.
Key exclusion criteria (5 listed)
- Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.
- Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.
- History of malignancy within 5 years (except certain cured skin/cervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases).
- Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes.
- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.
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 |
|---|---|---|
| LesigerceptSubcutaneous injection of Lesigercept | Drug | Lesigercept |
| PlaceboSubcutaneous injection of None of active ingredient | Drug | Placebo |
Primary outcome
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
Time frame: From first dose to Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
5 secondary outcomes
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12
Time frame: From first dose to Week 12
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12
Time frame: From first dose to Week 12
Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12
Time frame: From first dose to Week 12
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12
Time frame: From first dose to Week 12
Occurrence and severity of adverse events (AEs)
Time frame: Through study completion, approximately 113days
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 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to jieon.lee@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
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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.
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lesigercept in people with Allergic Diseases and Chronic Spontaneous Urticaria (CSU), run by Yuhan Corporation at 30 sites in 4 countries.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Poland, South Korea, Bulgaria, 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?
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 JinHyun Choi (+82-2-828-0850, clinicaltrials@yuhan.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12 (time frame: From first dose to 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 15 Apr 2026.