Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BLU-808 · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Arm A1 (Part A): BLU-808 | EXPERIMENTAL | BLU-808 will be administered orally. |
| Arm A3 (Part A): BLU-808 | EXPERIMENTAL | BLU-808 will be administered orally. |
| Arm B (Part B): BLU-808/Placebo | EXPERIMENTAL | BLU-808 or matching placebo will be administered orally. |
| BLU-808 Dose 1 | EXPERIMENTAL | BLU-808 will be administered orally for 28 days. |
| BLU-808 Dose 2 | EXPERIMENTAL | BLU-808 will be administered orally for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered orally for 28 days. |
| Part 1: BLU-808 | EXPERIMENTAL | BLU-808 will be administered orally. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Matching placebo for BLU-808 will be administered orally. |
| Part 2: BLU-808 | EXPERIMENTAL | BLU-808 will be administered orally. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Matching placebo for BLU-808 will be administered orally. |
| Part 2: Midazolam Alone Followed by BLU-808 and Midazolam | EXPERIMENTAL | Participants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2. |
| Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam | PLACEBO_COMPARATOR | Participants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2. |
| Part 3: BLU-808 (Treatment D, E) | EXPERIMENTAL | BLU-808 will be administered orally. |
| Part 3: BLU-808 (Treatment E, D) | EXPERIMENTAL | BLU-808 will be administered orally. |
| Name | Type | Description |
|---|---|---|
| BLU-808 | DRUG | Oral administration |
| Placebo | DRUG | Oral administration |
| Midazolam | DRUG | Midazolam will be administered per schedule specified in the arm description. |
Key Inclusion Criteria: * 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-antihista...
BLU-808 is an investigational small molecule being studied for allergic rhinoconjunctivitis, chronic inducible urticaria, and chronic spontaneous urticaria. It is also being evaluated in healthy participants to assess its safety and pharmacological profile.
BLU-808 is being developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol BPMC.
BLU-808 is in Phase 2 clinical development for allergic rhinoconjunctivitis and chronic inducible urticaria. A Phase 1 study in healthy participants has been completed.
BLU-808 has been studied in NCT06922448 for allergic rhinoconjunctivitis, NCT06931405 for chronic inducible and chronic spontaneous urticaria, and NCT06948032 in healthy adult participants. The urticaria trial is active but not recruiting, while the other two are completed.
BLU-808 is not FDA approved. It is an investigational drug currently in clinical development, with Phase 2 trials completed or ongoing for chronic urticaria and allergic rhinoconjunctivitis.
Yes, BLU-808 has been evaluated in a completed Phase 1 study (NCT06948032) that enrolled 95 healthy adult participants in the United States.