Clinical Trials List
Protocol NumberBLU-808-1201
Active
2025-08-01 - 2027-04-09
Phase II
Recruiting6
ICD-10L50.0
Allergic urticaria
ICD-9708.0
Allergic urticaria
A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
Blueprint Medicines Corporation
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Hua-En Lee Division of Dermatology
- Chun-Bing Chen Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Ya-Ching Chang Division of Dermatology
- Chun-Wei Lu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- WEI-HSIN WU Division of Dermatology
- 卓雍哲 Division of Dermatology
- 謝博丞 Division of Dermatology
- 黃柏瑋 Division of Dermatology
- 陳柏樺 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Woan-Ruoh Lee
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃瑞雲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
Objectives
This is a study to evaluate the safety, tolerability, and clinical activity of BLU-808 in the
treatment of CIndU and CSU. The data generated will be used to support further development of
BLU-808 as an IP.
Test Drug
tablet
Active Ingredient
BLU-808
Placebo
Placebo
Dosage Form
110
110
110
Dosage
1 mg
Endpoints
To characterize the safety and tolerability of BLU-808
Inclution Criteria
Part A: Chronic Inducible Urticaria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Adults ≥ 18 years of age at the time of signing the informed consent.
2. Must have confirmed diagnosis of CIndU for ≥ 3 months prior to Day 1 that is
inadequately controlled with second generation H1-antihistamines as defined by:
a. ColdU: wheal development at the test site within 10 minutes after using TempTest at
≥ 10°C at Screening.
b. SD: wheal development at the test site within 10 minutes after using FricTest with
≥ 3 pins at Screening.
c. Other CIndU: wheals after provocation test (refer to Appendix 5 for further details) at
Screening.
Note: In the subset of participants with CSU and co-occurring CIndU, all Part B CSU
inclusion criteria must additionally be met to confirm eligibility.
3. Use of second generation H1-antihistamines, if any, must be stable for ≥ 2 weeks prior to
Day 1 and throughout the study.
4. Able to swallow an oral medication.
5. Male participants who are surgically sterile (vasectomized) or fertile males that have
completed family planning (not planning to have biological children in the future).
6. For women of childbearing potential and fertile (non-vasectomized) males, use of highly
effective contraception or agreement to abstain from sexual intercourse consistent with
the protocol and local regulations, as outlined in Section 5.4 during the study drug
administration period and for at least 28 days after the last dose of study drug.
7. Male participants agree to abstain from sperm donation during the study drug
administration period and for at least 90 days after the last dose of study drug.
8. Participant or legal guardian provides signed informed consent to participate in the study.
Part B: Chronic Spontaneous Urticaria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Adults ≥ 18 years of age at the time of signing the informed consent.
2. Must have confirmed diagnosis of CSU for ≥ 6 months prior to Day 1 that is inadequately
controlled with second generation H1-antihistamines as defined by:
a. The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Day 1.
b. UAS7 ≥ 16 during the 7 days prior to Day 1 (refer to Section 8.6.2.1 for additional
details).
Note: In the subset of participants with CSU and co-occurring CIndU, all Part A CIndU
inclusion criteria must additionally be met to confirm eligibility.
3. Use of second generation H1-antihistamines must be stable for ≥ 2 weeks prior to Day 1
and throughout the study.
4. Able to swallow an oral medication.
5. Male participants who are surgically sterile (vasectomized) or fertile males that have
completed family planning (not planning to have biological children in the future).
6. For women of childbearing potential and fertile (non-vasectomized) males, use of highly
effective contraception or agreement to abstain from sexual intercourse consistent with
the protocol and local regulations, as outlined in Section 5.4 during the study drug
administration period and for at least 28 days after the last dose of study drug.
7. Male participants agree to abstain from sperm donation during the study drug
administration period and for at least 90 days after the last dose of study drug.
8. Participant or legal guardian provides signed informed consent to participate in the study.
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Adults ≥ 18 years of age at the time of signing the informed consent.
2. Must have confirmed diagnosis of CIndU for ≥ 3 months prior to Day 1 that is
inadequately controlled with second generation H1-antihistamines as defined by:
a. ColdU: wheal development at the test site within 10 minutes after using TempTest at
≥ 10°C at Screening.
b. SD: wheal development at the test site within 10 minutes after using FricTest with
≥ 3 pins at Screening.
c. Other CIndU: wheals after provocation test (refer to Appendix 5 for further details) at
Screening.
Note: In the subset of participants with CSU and co-occurring CIndU, all Part B CSU
inclusion criteria must additionally be met to confirm eligibility.
3. Use of second generation H1-antihistamines, if any, must be stable for ≥ 2 weeks prior to
Day 1 and throughout the study.
4. Able to swallow an oral medication.
5. Male participants who are surgically sterile (vasectomized) or fertile males that have
completed family planning (not planning to have biological children in the future).
6. For women of childbearing potential and fertile (non-vasectomized) males, use of highly
effective contraception or agreement to abstain from sexual intercourse consistent with
the protocol and local regulations, as outlined in Section 5.4 during the study drug
administration period and for at least 28 days after the last dose of study drug.
7. Male participants agree to abstain from sperm donation during the study drug
administration period and for at least 90 days after the last dose of study drug.
8. Participant or legal guardian provides signed informed consent to participate in the study.
Part B: Chronic Spontaneous Urticaria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Adults ≥ 18 years of age at the time of signing the informed consent.
2. Must have confirmed diagnosis of CSU for ≥ 6 months prior to Day 1 that is inadequately
controlled with second generation H1-antihistamines as defined by:
a. The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Day 1.
b. UAS7 ≥ 16 during the 7 days prior to Day 1 (refer to Section 8.6.2.1 for additional
details).
Note: In the subset of participants with CSU and co-occurring CIndU, all Part A CIndU
inclusion criteria must additionally be met to confirm eligibility.
3. Use of second generation H1-antihistamines must be stable for ≥ 2 weeks prior to Day 1
and throughout the study.
4. Able to swallow an oral medication.
5. Male participants who are surgically sterile (vasectomized) or fertile males that have
completed family planning (not planning to have biological children in the future).
6. For women of childbearing potential and fertile (non-vasectomized) males, use of highly
effective contraception or agreement to abstain from sexual intercourse consistent with
the protocol and local regulations, as outlined in Section 5.4 during the study drug
administration period and for at least 28 days after the last dose of study drug.
7. Male participants agree to abstain from sperm donation during the study drug
administration period and for at least 90 days after the last dose of study drug.
8. Participant or legal guardian provides signed informed consent to participate in the study.
Exclusion Criteria
Part A: Chronic Inducible Urticaria
Participants are excluded from the study if any of the following criteria apply:
1. Any active urticaria that may interfere with study assessments. Co-occurring CSU is
allowed in a subset of up to 5 participants in Arms A1, A2, and A3, and approximately
15 participants in A4 if there is a positive provocation test (refer to Appendix 5 for
details).
Note: In this subset of participants with CSU and co-occurring CIndU, all Part B CSU
exclusion criteria apply, except for exclusion criterion 1.
2. Any other skin disease associated with chronic itching or angioedema that might
influence the study evaluations and results (eg, urticarial vasculitis, AD, PN,
mastocytosis, uremic pruritus, bullous pemphigoid, dermatitis herpetiformis, and senile
pruritus), skin diseases associated with only wheals and no itch (eg, asymptomatic
dermographism), or autoinflammatory diseases with urticarial lesions (eg, Schnitzler
Syndrome).
3. History of cold-induced anaphylaxis.
Part B: Chronic Spontaneous Urticaria
Participants are excluded from the study if any of the following criteria apply:
1. Participant has a clearly defined predominant cause of CU or sole trigger such as SD and
ColdU (not applicable to participants in Part B2 with CSU and co-occurring CIndU).
2. Arm B1: Any other active skin disease associated with chronic itching or angioedema
that might influence the study evaluations and results (eg, urticarial vasculitis, AD, PN,
mastocytosis, uremic pruritus, bullous pemphigoid, dermatitis herpetiformis, and senile
pruritus), skin diseases associated with only wheals and no itch (eg, asymptomatic
dermographism), or autoinflammatory diseases with urticarial lesions (eg, Schnitzler
Syndrome).
Participants are excluded from the study if any of the following criteria apply:
1. Any active urticaria that may interfere with study assessments. Co-occurring CSU is
allowed in a subset of up to 5 participants in Arms A1, A2, and A3, and approximately
15 participants in A4 if there is a positive provocation test (refer to Appendix 5 for
details).
Note: In this subset of participants with CSU and co-occurring CIndU, all Part B CSU
exclusion criteria apply, except for exclusion criterion 1.
2. Any other skin disease associated with chronic itching or angioedema that might
influence the study evaluations and results (eg, urticarial vasculitis, AD, PN,
mastocytosis, uremic pruritus, bullous pemphigoid, dermatitis herpetiformis, and senile
pruritus), skin diseases associated with only wheals and no itch (eg, asymptomatic
dermographism), or autoinflammatory diseases with urticarial lesions (eg, Schnitzler
Syndrome).
3. History of cold-induced anaphylaxis.
Part B: Chronic Spontaneous Urticaria
Participants are excluded from the study if any of the following criteria apply:
1. Participant has a clearly defined predominant cause of CU or sole trigger such as SD and
ColdU (not applicable to participants in Part B2 with CSU and co-occurring CIndU).
2. Arm B1: Any other active skin disease associated with chronic itching or angioedema
that might influence the study evaluations and results (eg, urticarial vasculitis, AD, PN,
mastocytosis, uremic pruritus, bullous pemphigoid, dermatitis herpetiformis, and senile
pruritus), skin diseases associated with only wheals and no itch (eg, asymptomatic
dermographism), or autoinflammatory diseases with urticarial lesions (eg, Schnitzler
Syndrome).
The Estimated Number of Participants
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Taiwan
18 participants
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Global
150 participants
