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

NCT06931405 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BLU-808-12012024-520031-33-00
• Study Type: interventional
• Target: 105
• Locations: 6 countries
• Sites: 47

Brief 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).

Conditions

Chronic Inducible Urticaria; Chronic Spontaneous Urticaria

Keywords

Chronic Inducible Urticaria; Chronic Spontaneous Urticaria; BLU-808; CIndU; CSU; Chronic Urticaria; CU; Cold Urticaria; ColdU; Symptomatic Dermographism; SD

Outcome Measures

Primary Outcomes (1)

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

  Day 1 through Week 16

Secondary Outcomes (12)

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

  Baseline, Week 12

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

  Baseline, Week 12

• Part A and Part B: Complete Response Rate

  Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

Study Arms (3)

Arm A1 (Part A): BLU-808

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Arm A3 (Part A): BLU-808

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Arm B (Part B): BLU-808/Placebo

EXPERIMENTAL

BLU-808 or matching placebo will be administered orally.

Drug: BLU-808; Drug: Placebo

Interventions

BLU-808 DRUG

Oral administration

Arm A1 (Part A): BLU-808; Arm A3 (Part A): BLU-808; Arm B (Part B): BLU-808/Placebo

Placebo DRUG

Oral administration

Arm B (Part B): BLU-808/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

Study Sites (47)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Acuro Research, Inc.

Little Rock, Arkansas, 72205, United States

Location

Modena Allergy & Asthma Clinical Research - La Jolla

La Jolla, California, 92037, United States

Location

Allergy & Asthma Associates of Southern California

Laguna Niguel, California, 92677, United States

Location

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Allergy Affiliates Inc.

Bradenton, Florida, 34208, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Endeavor Health

Northbrook, Illinois, 60062, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Institute For Asthma & Allergy

Wheaton, Maryland, 20902, United States

Location

Chesapeake Clinical Research

White Marsh, Maryland, 21236, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Clinical Research Center LLC.

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Equity Medical (at Cameron Dermatology) - New York

New York, New York, 10023, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45236, United States

Location

Allergy & Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

National Allergy, Asthma & Urticaria Centers of Charleston

Charleston, South Carolina, 29407, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Reveal Research Institute

Dallas, Texas, 75235, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Odense University Hospital - Odense

Odense, 5000, Denmark

Location

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

Berlin, 12203, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

Frankfurt am Main, 60596, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72016, Germany

Location

Azienda Ospedale - Università Padova

Padova, 35128, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Umberto

Rome, 00161, Italy

Location

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134, Italy

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Kaohsiung Veterans General Hospital (KSVGH)

Kaohsiung City, 813414, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

China Medical University Hospital

Taichung, 40402, Taiwan

Location

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Linkou Chang Gung Memorial Hospital (CGMHLK)

Taoyuan City, 105406, Taiwan

Location

MeSH Terms

Conditions

Chronic Inducible Urticaria; Chronic Urticaria; Cold Urticaria; Familial dermographism

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Arms A1 and A3 are non-randomized and open label. Arm B is randomized and double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

ES (4); IT (3); US (27); DK (1); TW (6); DE (6)