Actively Recruiting
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)
Led by Yuhan Corporation · Updated on 2026-04-15
150
Participants Needed
30
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of lesigercept in adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines, including those previously treated with omalizumab. This phase 2 trial aims to provide evidence on lesigercept's clinical usefulness and better understand its benefit and risk profile in this patient group. About 150 participants will be randomly assigned in a 2:1 ratio to receive either lesigercept or a placebo. The treatment phase lasts 12 weeks, with lesigercept or placebo given by subcutaneous injection every 4 weeks for a total of three doses. Following treatment, participants will be monitored for an additional 4 weeks. During the 16-week study, participants will have their urticaria activity scores tracked along with safety evaluations, pharmacokinetics, pharmacodynamics, and immune response monitoring. Researchers will assess symptom control, quality of life, and adverse events. The study includes regular symptom diaries, clinical assessments, and laboratory tests to gather comprehensive data on lesigercept’s effects.
CONDITIONS
Brief Title
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Chronic spontaneous urticaria for at least 6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7 16, ISS7 8, HSS7 8)
- Stable dose of 2nd-generation H1-antihistamines for at least 7 days
- Symptom diary compliance of at least 80%
- At least 80% adherence to antihistamines during screening
- Signed informed consent
- Contraception and pregnancy test requirements for both genders
You will not qualify if you...
- Medical or lab findings indicating risk of worsening co-existing conditions during the study
- Significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders
- History of malignancy within 5 years, except certain cured skin or cervical cancers
- Chronic urticaria with known causes other than CSU (e.g., inducible urticaria, autoimmune diseases)
- Active or high-risk parasitic infections, chronic or recurrent infections (e.g., TB, HBV, HCV, HIV)
- Hypersensitivity or anaphylaxis to study drugs or related classes
- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis)
- History of drug or alcohol abuse within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive either Lesigercept or placebo by subcutaneous injection every 4 weeks for a total of three doses.
3 visits (in-person) every 4 weeks for dosing
Duration - 4 weeks
Participants are monitored for safety and other outcomes after the treatment period ends.
1 visit (in-person)
Trial Site Locations
Total: 30 locations
1
Diagnostic & Consultative Centre Ascendent EOOD
Sofia, Sofia, Bulgaria, 1202
Not Yet Recruiting
2
UMHAT "Aleksandrovska"
Sofia, Sofia, Bulgaria, 1431
Not Yet Recruiting
3
Medical Center Hera EOOD
Sofia, Sofia, Bulgaria, 1510
Not Yet Recruiting
4
UMHATEM "N. I. Pirogov"
Sofia, Sofia, Bulgaria, 1606
Not Yet Recruiting
5
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
6
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Not Yet Recruiting
7
Alergologia Plus Sp. z o. o.
Poznan, Greater Poland Voivodeship, Poland, 60-693
Not Yet Recruiting
8
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, Poland, 30-033
Not Yet Recruiting
9
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland, 31-011
Not Yet Recruiting
10
Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Not Yet Recruiting
11
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, Lower Silesian Voivodeship, Poland, 53-201
Not Yet Recruiting
12
DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne
Wroclaw, Lower Silesian Voivodeship, Poland, 53-613
Not Yet Recruiting
13
Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny
Lublin, Lublin Voivodeship, Poland, 20-573
Not Yet Recruiting
14
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opolskie Voivodeship, Poland, 45-401
Not Yet Recruiting
15
Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko
Bialystok, Podlaskie Voivodeship, Poland, 15-010
Not Yet Recruiting
16
Bio Zdrowie sp. z o.o.
Bialystok, Podlaskie Voivodeship, Poland, 15-698
Not Yet Recruiting
17
NZOZ GynCentrum Oddział Libero
Katowice, Silesian Voivodeship, Poland, 40-600
Not Yet Recruiting
18
Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)
Katowice, Silesian Voivodeship, Poland, 40-611
Not Yet Recruiting
19
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, South Korea, 13620
Not Yet Recruiting
20
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea, 42601
Actively Recruiting
21
Korea University Ansan Hospital
Gyeonggi-do, Danwon-gu, South Korea, 15355
Not Yet Recruiting
22
Chung-Ang University Hospital
Seoul, Dongjak-gu, South Korea, 06973
Actively Recruiting
23
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Not Yet Recruiting
24
Inha University Hospital
Incheon, Incheon, South Korea, 22332
Not Yet Recruiting
25
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Seocho-gu, South Korea, 06591
Actively Recruiting
26
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, South Korea, 03722
Not Yet Recruiting
27
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, South Korea, 05278
Not Yet Recruiting
28
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul, South Korea, 07441
Not Yet Recruiting
29
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Not Yet Recruiting
30
Ajou University Hospital
Gyeonggi-do, Suwon, South Korea, 16499
Not Yet Recruiting
Research Team
J
JinHyun Choi
J
JeungJin Yoon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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