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Chronic Inducible UrticariaPhase 2NCT06931405

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

A Phase 2 study testing BLU-808 in people with Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, run by Blueprint Medicines Corporation at 47 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BLU-808
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
47 sitesin 6 countries
Study dates
28 May 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
  • Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.

Who cannot join

  • Part A: Any active urticaria that may interfere with study assessments.
  • Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.
  • Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.
  • Part A and Part 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.
  • Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
  • Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.

Trial locations and contacts

47 sites in 6 countries.

47 sites in 6 countries

United States27 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Allervie Clinical Research

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104

  • Allergy Affiliates Inc.

    Bradenton, Florida, 34208

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston, South Carolina, 29407

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45236

  • Reveal Research Institute

    Dallas, Texas, 75235

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Modena Allergy & Asthma Clinical Research - La Jolla

    La Jolla, California, 92037

  • Allergy & Asthma Associates of Southern California

    Laguna Niguel, California, 92677

  • Acuro Research, Inc.

    Little Rock, Arkansas, 72205

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Equity Medical (at Cameron Dermatology) - New York

    New York, New York, 10023

  • Endeavor Health

    Northbrook, Illinois, 60062

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • Allergy & Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Allergy & Asthma Medical Group and Research Center

    San Diego, California, 92123

  • The Clinical Research Center LLC.

    St Louis, Missouri, 63141

  • University of South Florida

    Tampa, Florida, 33613

  • Institute For Asthma & Allergy

    Wheaton, Maryland, 20902

  • Chesapeake Clinical Research

    White Marsh, Maryland, 21236

Other trials in United States

Germany6 sites

  • Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin

    Berlin, 12203

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt am Main, 60596

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

  • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

    Mainz, 55131

  • Universitaetsklinikum Tuebingen

    Tübingen, 72016

Other trials in Germany

Taiwan6 sites

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300

  • Kaohsiung Veterans General Hospital (KSVGH)

    Kaohsiung City, 813414

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 235

  • China Medical University Hospital

    Taichung, 40402

  • National Taiwan University Hospital

    Taipei, 100225

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City, 105406

Other trials in Taiwan

Spain4 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

Other trials in Spain

Italy3 sites

  • Azienda Ospedale - Università Padova

    Padova, 35128

  • Azienda Ospedaliero Universitaria Policlinico Umberto

    Rome, 00161

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134

Other trials in Italy

Denmark1 site

  • Odense University Hospital - Odense

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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

This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).

Being tested
BLU-808, Placebo
Keywords
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria, BLU-808, CIndU, CSU, Chronic Urticaria, CU, Cold Urticaria, ColdU, Symptomatic Dermographism, SD
Medical subject headings
Chronic Inducible Urticaria, Chronic Urticaria, Cold Urticaria, Familial dermographism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLU-808Drug

    Oral administration

  • PlaceboDrug

    Oral administration

Study groups in NCT06931405
Study groupRoleWhat they receive
Arm A1 (Part A): BLU-808ExperimentalBLU-808 will be administered orally.
Receives: Drug: BLU-808
Arm A3 (Part A): BLU-808ExperimentalBLU-808 will be administered orally.
Receives: Drug: BLU-808
Arm B (Part B): BLU-808/PlaceboExperimentalBLU-808 or matching placebo will be administered orally.
Receives: Drug: BLU-808; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Day 1 through Week 16

Secondary outcomes (12)

  1. Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12

    CTT is the temperature at which CIndU symptoms appear.

    Measured: Baseline, Week 12

  2. Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12

    TFS is a measure of CIndU trigger thresholds and disease activity.

    Measured: Baseline, Week 12

  3. Part A and Part B: Complete Response Rate

    Measured: Week 12

  4. Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12

    Measured: Baseline, Week 12

  5. Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12

    Measured: Baseline, Week 12

  6. Part A and Part B: Area Under the Curve (AUC) of BLU-808

    Measured: Day 1 to Day 57

  7. Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808

    Measured: Day 1 to Day 57

  8. Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808

    Measured: Day 1 to Day 57

  9. Part A and Part B: Apparent Clearance (CL/F) of BLU-808

    Measured: Day 1 to Day 57

  10. Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808

    Measured: Day 1 to Day 57

  11. Part A and Part B: Terminal Half-life (t½) of BLU-808

    Measured: Day 1 to Day 57

  12. Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12

    UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start28 May 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931405
Sponsor's protocol ID
BLU-808-1201
Other IDs
2024-520031-33-00
Status last verified
Jul 2026
First submitted
9 Apr 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BLU-808 in people with Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, run by Blueprint Medicines Corporation at 47 sites in 6 countries.

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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Germany, Taiwan, Spain, Italy and 1 more country. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931405.

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 22 Jul 2026.

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