A Phase 2 interventional study of BLU-808 and Placebo in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, sponsored by Blueprint Medicines Corporation. Active, not recruiting at 47 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Blueprint Medicines Corporation (part of Sanofi) · Phase 2, Interventional, and Treatment
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Among 64 studies in Chronic Urticaria with a site in United States — 9 open to participants now, 17 under way, 6 of them phase 3. Chronic Urticaria · United States.
Among the 64 studies in Chronic Urticaria with a site in United States, this one is the 32nd largest by planned enrollment of the 58 interventional ones that give a count, is one of 9 that started in 2025, is one of 23 in phase 2, reaches primary completion later than 7 of the 16 other live ones, and was the 56th registered.
195 studies on the registry are indexed under Chronic Urticaria; 48 are open to participants now.
Browse Chronic Urticaria studies →9 of the 64 studies in Chronic Urticaria with a site in United States are open now. Recruiting first, the newest first:
Calixis Inc. · Sites in United States
Ages 18–85
Enanta Pharmaceuticals, Inc · Sites in United States
Ages 18–65 · Healthy volunteers
Novartis Pharmaceuticals · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18–100
Novartis Pharmaceuticals · Sites in United States
Ages 18–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Chronic Urticaria studies recruiting now, 11 (44%) set no upper age limit and 10 (40%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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64 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 25 · Phase 3 22 · Phase 4 4
First in 2008; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 105 is above the median of 80 across 147 interventional studies indexed under Chronic Urticaria.
Median enrollment 132 across the 58 interventional studies, 428 across the 6 observational. Of the 44 that completed or were terminated, 30 (68%) have results posted.
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52 of 64 have an industry lead sponsor. The 10 most frequent:
This study is registered under Blueprint Medicines Corporation, one of the names counted as Sanofi. Under that name alone:
Blueprint Medicines Corporation is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 3 (21%) have results posted.
Sanofi has 5 studies filed under Chronic Urticaria — fewer than ten, so there is no comparison to draw.
6 of the studies in Chronic Urticaria with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06868212Phase 3Novartis PharmaceuticalsA Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines | 2027-02-22 |
| NCT07540910Enanta Pharmaceuticals, IncA Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults | 2026-11 |
| NCT07219615PfizerA Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | 2026-12-25 |
| NCT06931405Blueprint Medicines CorporationStudy of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) | 2026-12-31 |
| NCT06927999ARS Pharmaceuticals, Inc.An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria | 2027-06 |
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Among the 64 studies in Chronic Urticaria with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Key Inclusion Criteria:
Key Exclusion Criteria:
BLU-808 will be administered orally.
Drug: BLU-808
BLU-808 will be administered orally.
Drug: BLU-808
BLU-808 or matching placebo will be administered orally.
Drug: BLU-808 · Drug: Placebo
Oral administration
Oral administration
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Week 16
Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
CTT is the temperature at which CIndU symptoms appear.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
Part A and Part B: Complete Response Rate
Time frame: Week 12
Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12
Time frame: Baseline, Week 12
Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12
Time frame: Baseline, Week 12
Part A and Part B: Area Under the Curve (AUC) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Apparent Clearance (CL/F) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Time frame: Day 1 to Day 57
Part A and Part B: Terminal Half-life (t½) of BLU-808
Time frame: Day 1 to Day 57
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.
Time frame: Baseline, Week 12
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 31 phase 2 interventional studies under Chronic Urticaria, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's planned 19 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BLU-808
Blueprint Medicines Corporation →