Study of BLU-808 in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Blueprint Medicines Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

16 Sep 2025 → ongoing

Decision date (initial)

2025-09-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Blueprint Medicines Corporation

External identifiers

EU CT number

2024-520031-33-00

WHO UTN

U1111-1318-0550

ClinicalTrials.gov

NCT06931405

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Others, Safety

Part A/B: To characterize the safety and tolerability of BLU-808

Secondary objectives 2

1. Part A/B: To evaluate the clinical activity of BLU-808 on chronic inducible and chronic spontaneous urticaria activity
2. Part A/B: To evaluate the pharmacokinetic and pharmacodynamic profile of BLU-808

Conditions and MedDRA coding

Chronic Inducible Urticaria and Chronic Spontaneous Urticaria

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. 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
3. 3. Other protocol-defined criteria apply

Exclusion criteria 7

1. 1. Part A: Any active urticaria that may interfere with study assessments
2. 3. Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria
3. 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
4. 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
5. 6. Part A/B: Abnormal laboratory values that may pose risks or interfere with study participation
6. 7. Part A/B: Pregnancy or plans for pregnancy; breastfeeding
7. 8. Other protocol-defined criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events

Secondary endpoints 7

1. 1. Part A: Cold-induced urticaria: mean change in critical temperature threshold using TempTest from Baseline to the end of Week 12
2. 2. Part A: Symptomatic dermographism: mean change in total Fric score using FricTest from Baseline to the end of Week 12
3. 3. Part A: Complete response rate at the end of Week 12
4. 4. Part B: Mean change from Baseline to the end of Week 12 in patient reported outcome(s)
5. 5. Part B: Complete response rate at the end of Week 12
6. 6. Part A/B: Absolute and percent change in pharmacodynamic markers from Baseline to the end of Week 12
7. 7. Part A/B: Population pharmacokinetic parameters including but not limited to AUC, Cmax, Cmin, CL/F, Vc/F, and t1/2

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Blueprint Medicines Corp.

Sponsor organisation

Blueprint Medicines Corp.

Address

45 Sidney Street

City

Cambridge

Postcode

02139-4133

Country

United States

Scientific contact point

Organisation

Blueprint Medicines Corp.

Contact name

EU Medical Information

Public contact point

Organisation

Blueprint Medicines Corp.

Contact name

EU Medical Information

Third parties 13

Locations

4 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications