Chronic Spontaneous UrticariaPhase 2NCT06295302
A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria
A Phase 2 study testing HWH486 in people with Chronic Spontaneous Urticaria, run by Hubei Biological Medicine Industrial Technology Institute Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- HWH486
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2023to Jan 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, ≤70 years old;
- Participants with chronic spontaneous urticaria (CSU) at the time of randomization as defined by the following: presence of itch and hives for ≥ 6 consecutive weeks prior to screening, despite second generation H1-antihistamine during this period; Urticaria Activity Score (UAS7) (range 0-42) ≥16, Hives Severity Score (HSS7) (range 0-21) ≥ 6 and Itch Severity Score (ISS7) (range 0-21) ≥ 6 during 7 consecutive days prior to randomization; CSU duration ≥6 months prior to screening (defined as the onset of CSU as determined by the investigator based on all available supporting documentation).
- Willing and able to complete the Urticaria Participant Daily eDiary (UPDD) for the duration of the study;
- Willing to take background medication and emergency medication according to the study protocol.
- 6) Written informed consent signed voluntarily by the patient or their legal representatives.
Who cannot join
- Previous use of HWH486 or other Bruton's tyrosine kinase(BTK) inhibitors;
- Participants having a predominant or sole trigger of their chronic urticaria (chronic inducible urticaria);
- Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
- With symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with a history of gastrointestinal bleeding that is associated with a significant risk of bleeding or coagulopathy, or is clinically significant (such as requiring hospitalization or blood transfusion), or with other chronic medical conditions that are not eligible for participation in this clinical trial, or having a history of malignancy, other than non-metastatic basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of the cervix with appropriate treatment and no signs of recurrence;
- Clinically important laboratory test indicators are abnormal, including: abnormal blood routine: hemoglobin (Hb) < 100g/L, or white blood cell count (WBC) < 3.5×10^9/L; Abnormal liver function: aspartate aminotransferase (AST) ≥1.5×ULN, or alanyl aminotransferase (ALT) ≥1.5×ULN, or total bilirubin (TBIL) ≥1.5×ULN; Abnormal renal function: creatinine (Cr) ≥1×ULN; any other laboratory test indicators that researchers think may affect the evaluation of test results;
- Active and uncontrolled viral and bacterial infections at the time of screening, such as human immunodeficiency virus(HIV), hepatitis B virus(HBV), hepatitis C virus (HCV), syphilis, tuberculosis test results, or if there are any clinical symptoms of bacterial, viral, parasitic or fungal infection requiring treatment;
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- Pregnant or breastfeeding women; having pregnancy plans during the clinical trial and within 1 month after the last dose, and do not want to take medically accepted reliable contraceptive methods;
- History of allergy to any investigational therapeutic drug or its excipients;
- History or evidence of alcohol or drug abuse within the six months prior to randomization;
- Use of other immunosuppressive drugs, including but not limited to hydroxychloroquine, methotrexate, cyclosporin A, cyclophosphamide, tacrolimus, mycophenolate, tripterygium, and compound glycyrrhizin, within 30 days or 5 half-lives (whichever is older) prior to screening;
- The investigator determines that the subjects have any conditions that make them unfit to participate in the experiment (such as weak health, poor compliance, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital,Sichuan University
Chengdu, Sichuan
Bioethics Committee of West China Hospital, +86 28 8512 3237
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Study to Explore the Efficacy, Safety, and Pharmacokinetic Profile of HWH486 in Adults With Chronic Spontaneous Urticaria(CSU)
This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- HWH486, 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.
HWH486Drug
HWH486 capsule was administrated orally
PlaceboDrug
Matching placebo was administrated orally
| Study group | Role | What they receive |
|---|---|---|
| HWH486 | Experimental | Not described Receives: Drug: HWH486 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)
Weekly Urticaria Activity Score (UAS7; range 0-42; higher scores reflect greater disease activity)
Measured: Baseline, Week 4
Secondary outcomes (2)
Change in Hive Severity Score (HSS) over a 7-day period (HSS7)
Weekly Hives Severity Score (HSS7; range 0-21; higher scores reflect greater wheals)
Measured: Baseline to Week 4
Change in Itch Severity Score (ISS) over a 7-day period (ISS7)
Weekly Itch Severity Score (ISS7; range 0-21; higher scores reflect greater itching)
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start13 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295302
- Sponsor's protocol ID
- RFCU-IIa-202308
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Study to Explore the Efficacy, Safety, and Pharmacokinetic Profile of HWH486 in Adults With Chronic Spontaneous Urticaria(CSU)
- ClinicalTrials.gov ID
- NCT06295302
- Acronym / sponsor ID
- RFCU-IIa-202308
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.University, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Mar 2024 (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 multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated.
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 |
|---|---|---|
| HWH486 | Experimental | Drug: HWH486 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18, ≤70 years old;
- Participants with chronic spontaneous urticaria (CSU) at the time of randomization as defined by the following: presence of itch and hives for ≥ 6 consecutive weeks prior to screening, despite second generation H1-antihistamine during this period; Urticaria Activity Score (UAS7) (range 0-42) ≥16, Hives Severity Score (HSS7) (range 0-21) ≥ 6 and Itch Severity Score (ISS7) (range 0-21) ≥ 6 during 7 consecutive days prior to randomization; CSU duration ≥6 months prior to screening (defined as the onset of CSU as determined by the investigator based on all available supporting documentation).
- Willing and able to complete the Urticaria Participant Daily eDiary (UPDD) for the duration of the study;
- Willing to take background medication and emergency medication according to the study protocol.
- 6) Written informed consent signed voluntarily by the patient or their legal representatives.
Key exclusion criteria (11 listed)
- Previous use of HWH486 or other Bruton's tyrosine kinase(BTK) inhibitors;
- Participants having a predominant or sole trigger of their chronic urticaria (chronic inducible urticaria);
- Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
- With symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with a history of gastrointestinal bleeding that is associated with a significant risk of bleeding or coagulopathy, or is clinically significant (such as requiring hospitalization or blood transfusion), or with other chronic medical conditions that are not eligible for participation in this clinical trial, or having a history of malignancy, other than non-metastatic basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of the cervix with appropriate treatment and no signs of recurrence;
- Clinically important laboratory test indicators are abnormal, including: abnormal blood routine: hemoglobin (Hb) < 100g/L, or white blood cell count (WBC) < 3.5×10^9/L; Abnormal liver function: aspartate aminotransferase (AST) ≥1.5×ULN, or alanyl aminotransferase (ALT) ≥1.5×ULN, or total bilirubin (TBIL) ≥1.5×ULN; Abnormal renal function: creatinine (Cr) ≥1×ULN; any other laboratory test indicators that researchers think may affect the evaluation of test results;
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 |
|---|---|---|
| HWH486HWH486 capsule was administrated orally | Drug | HWH486 |
| PlaceboMatching placebo was administrated orally | Drug | Placebo |
Primary outcome
Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)
Time frame: Baseline, Week 4
Weekly Urticaria Activity Score (UAS7; range 0-42; higher scores reflect greater disease activity)
2 secondary outcomes
Change in Hive Severity Score (HSS) over a 7-day period (HSS7)
Time frame: Baseline to Week 4
Change in Itch Severity Score (ISS) over a 7-day period (ISS7)
Time frame: Baseline to Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HWH486 in people with Chronic Spontaneous Urticaria, run by Hubei Biological Medicine Industrial Technology Institute Co., Ltd. at 1 site 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 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie ZHU (+86 027 87055350, zhujie@renfu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) (time frame: Baseline, Week 4). 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 7 Mar 2024.