BLU-808 for Chronic inducible urticaria | Chronic spontaneous urticaria

Inclusion criteria

• {"criterion_text":"- 1. Part A: Confirmed diagnosis of chronic inducible urticaria for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines"}
• {"criterion_text":"- 2. Part B: Confirmed diagnosis of chronic spontaneous urticaria for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines"}
• {"criterion_text":"- 3. Other protocol-defined criteria apply"}

Exclusion criteria

• {"criterion_text":"- 1. Part A: Any active urticaria that may interfere with study assessments"}
• {"criterion_text":"- 3. Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria"}
• {"criterion_text":"- 4. Part A/B: Any other skin disease associated with chronic itching, angioedema, or that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions"}
• {"criterion_text":"- 5. Part A/B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results"}
• {"criterion_text":"- 6. Part A/B: Abnormal laboratory values that may pose risks or interfere with study participation"}
• {"criterion_text":"- 7. Part A/B: Pregnancy or plans for pregnancy; breastfeeding"}
• {"criterion_text":"- 8. Other protocol-defined criteria apply"}

Primary endpoints

• {"endpoint_text":"- Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events","definition_or_measurement_approach":"Assessed by the type, frequency, severity, and causality of Adverse Events as recorded during the study"}

Secondary endpoints

• {"endpoint_text":"- 1. Part A: Cold-induced urticaria: mean change in critical temperature threshold using TempTest from Baseline to the end of Week 12","definition_or_measurement_approach":"Mean change in critical temperature threshold measured with TempTest from Baseline to Week 12"}
• {"endpoint_text":"- 2. Part A: Symptomatic dermographism: mean change in total Fric score using FricTest from Baseline to the end of Week 12","definition_or_measurement_approach":"Mean change in total Fric score measured with FricTest from Baseline to Week 12"}
• {"endpoint_text":"- 3. Part A: Complete response rate at the end of Week 12","definition_or_measurement_approach":"Proportion of participants achieving complete response by Week 12 (definition per protocol)"}
• {"endpoint_text":"- 4. Part B: Mean change from Baseline to the end of Week 12 in patient reported outcome(s)","definition_or_measurement_approach":"Mean change in specified patient-reported outcome measures from Baseline to Week 12"}
• {"endpoint_text":"- 5. Part B: Complete response rate at the end of Week 12","definition_or_measurement_approach":"Proportion of participants achieving complete response by Week 12 (definition per protocol)"}
• {"endpoint_text":"- 6. Part A/B: Absolute and percent change in pharmacodynamic markers from Baseline to the end of Week 12","definition_or_measurement_approach":"Absolute and percent changes in predefined pharmacodynamic markers from Baseline to Week 12"}
• {"endpoint_text":"- 7. Part A/B: Population pharmacokinetic parameters including but not limited to AUC, Cmax, Cmin, CL/F, Vc/F, and t1/2","definition_or_measurement_approach":"Population PK parameters (AUC, Cmax, Cmin, CL/F, Vc/F, t1/2) derived from PK sampling and population PK analysis"}

Germany

Earliest CTIS Part Ii Submission Date

05-08-2025

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

198

Number Of Sites

6

Number Of Participants

24

Denmark

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

187

Number Of Sites

1

Number Of Participants

7

Italy

Earliest CTIS Part Ii Submission Date

06-08-2025

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

197

Number Of Sites

3

Number Of Participants

13

Spain

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

188

Number Of Sites

4

Number Of Participants

13

Primary sponsor

Full Name

Blueprint Medicines Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

[{"code":8}]

Name

Medpace Finland Oy

Responsibilities

[{"code":1},{"code":12},{"code":13},{"code":15,"value":"IDMC setup and management, CSR preparation"},{"code":2},{"code":4},{"code":5},{"code":6},{"code":7},{"code":8}]

Name

4g Clinical LLC

Responsibilities

[{"code":3}]

Third parties

• {"country":"United States","full_name":"Virant Diagnostics Inc.","duties_or_roles":"[{\"code\":4}]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"[{\"code\":4}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"code\":8}]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Phlexglobal Limited","duties_or_roles":"[{\"code\":15,\"value\":\"TMF\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"code\":7}]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Biopier Inc.","duties_or_roles":"[{\"code\":10}]","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"[{\"code\":1},{\"code\":12},{\"code\":13},{\"code\":15,\"value\":\"IDMC setup and management, CSR preparation\"},{\"code\":2},{\"code\":4},{\"code\":5},{\"code\":6},{\"code\":7},{\"code\":8}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"[{\"code\":15,\"value\":\"imaging / photographs\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"[{\"code\":3}]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Novovita Histopath Laboratory LLC","duties_or_roles":"[{\"code\":4}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"[{\"code\":4}]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"[{\"code\":15,\"value\":\"PV medical review, Qualified Person for PV (QPPV), SOP authoring, DSURs & global lit searches\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"[{\"code\":4}]","organisation_type":"Laboratory/Research/Testing facility"}