BLU-808 for Chronic Urticaria

Recruiting at 39 trial locations

Overseen By Blueprint Medicines

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Blueprint Medicines Corporation

Must be taking: Second generation H1-antihistamines

Disqualifiers: Active urticaria, Cold anaphylaxis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BLU-808 for individuals with certain types of chronic urticaria (long-lasting hives). The goal is to determine if BLU-808 is safe and effective for those whose hives are not well-controlled by typical allergy medications. The trial consists of two parts: one for individuals with chronic induced urticaria (hives triggered by specific factors) and another for those with chronic spontaneous urticaria (hives with no clear cause). Suitable candidates for the trial have experienced either type of hives for at least three months and continue to struggle with symptoms despite taking second-generation antihistamines. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for those whose condition is not controlled by second generation H1-antihistamines, you may be able to continue those medications.

Is there any evidence suggesting that BLU-808 is likely to be safe for humans?

Research has shown that BLU-808, a treatment being tested for chronic hives, appears to be safe. Early data indicate that BLU-808 is generally well tolerated, with most people not experiencing serious side effects. The body absorbs it well, allowing for effective once-a-day dosing.

Regarding side effects, similar treatments have shown low rates of discontinuation due to side effects. For instance, related studies reported that only about 3% of participants stopped because of treatment-related issues. While these results are promising, it's important to remember that every new treatment can affect people differently. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BLU-808 is unique because it offers a potential new approach for treating chronic urticaria, a condition typically managed with antihistamines or corticosteroids. Unlike these standard treatments, BLU-808 is administered orally and may provide an alternative mechanism of action. Researchers are excited about BLU-808 because it could target the root causes of chronic urticaria differently, possibly improving symptoms for patients who don't respond well to existing options. Additionally, the inclusion of a placebo arm in the trial helps researchers assess the true efficacy of BLU-808, which could lead to a more tailored treatment strategy for chronic urticaria.

What evidence suggests that BLU-808 might be an effective treatment for chronic urticaria?

Research shows that BLU-808 might help treat chronic urticaria by affecting mast cells, which are part of the immune system and play a role in allergic reactions and inflammation. Studies have found that BLU-808 can decrease these cells, with effectiveness increasing with dosage. This reduction helps alleviate symptoms like itching and hives. Early results also suggest potential benefits for related conditions, offering promise for those with chronic urticaria. Participants in this trial will receive BLU-808 in different treatment arms, while some will receive a placebo for comparison. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people who've had Chronic Inducible Urticaria (CIndU) for at least 3 months or Chronic Spontaneous Urticaria (CSU) for at least 6 months, and their symptoms aren't well-managed with common antihistamines. Participants must have a confirmed diagnosis.

Inclusion Criteria

I have had chronic inducible urticaria for over 3 months not managed by antihistamines.

I have had chronic hives for 6 months or more and antihistamines don't control it well.

Exclusion Criteria

Part A: Any active urticaria that may interfere with study assessments

Part A: History of cold-induced anaphylaxis

Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BLU-808 or placebo orally to evaluate safety, tolerability, and clinical activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BLU-808

Trial Overview The study tests BLU-808, a drug intended to inhibit certain cellular processes that may be involved in urticaria. It's compared against a placebo in two parts: one focusing on CIndU patients and the other on CSU patients.

How Is the Trial Designed?

Group I: Arm B (Part B): BLU-808/Placebo Experimental Treatment 2 Interventions

BLU-808 or matching placebo will be administered orally.

Group II: Arm A3 (Part A): BLU-808 Experimental Treatment 1 Intervention

BLU-808 will be administered orally.

Group III: Arm A1 (Part A): BLU-808 Experimental Treatment 1 Intervention

BLU-808 will be administered orally.

Who Is Running the Clinical Trial?

Blueprint Medicines Corporation

Lead Sponsor

Trials

31

Recruited

6,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06931405?cond=%22Familial%20Dermographism%22&viewType=Table&rank=2

NCT06931405 | Study of BLU-808 in Chronic Inducible ... This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, ...

2. blueprintmedicines.com blueprintmedicines.com/wp-content/uploads/2024/02/Blueprint-Medicines-Press-Release-AAAAI-2024-February-23-2024.pdf

Blueprint Medicines Highlights AYVAKIT® (avapritinib) ... In multiple in vivo studies, BLU-808 treatment led to dose-dependent inhibition and depletion of mast cells. In addition, BLU-808 improved lung ...

3. prnewswire.com prnewswire.com/news-releases/blueprint-medicines-provides-2025-outlook-and-highlights-strategy-for-continued-growth-302348688.html

Blueprint Medicines Provides 2025 Outlook and Highlights ... "The results show that BLU-808 performed consistently, with dose ... Initiate proof-of-concept trials in chronic spontaneous urticaria, chronic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825005008

Advancements in Novel Therapeutics for Chronic ... Remibrutinib, an oral BTK inhibitor, completed phase 2b and 3 clinical trials and was found to be effective in reducing urticaria disease ...

5. ctv.veeva.com ctv.veeva.com/study/study-of-blu-808-in-chronic-inducible-urticaria-cindu-and-chronic-spontaneous-urticaria-csu

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and ... This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and ...

6. rarediseaseadvisor.com rarediseaseadvisor.com/news/blueprint-medicines-reveals-promising-data-on-avapritinib-and-blu-80/

Study Results Show Efficacy and Safety of Avapritinib in ... Treatment-related adverse events led to treatment discontinuation in 3% of cases. “The development of BLU-808 is another example of our proven ...

7. jacionline.org jacionline.org/article/S0091-6749(24)01990-0/fulltext

Safety and Pharmacokinetics (PK) of BLU-808 Following ... Preliminary data indicate that BLU-808 has good oral bioavailability with PK supportive of once-daily dosing. To date, BLU-808 has been generally well tolerated ...