EP262 for Chronic Hives

(CALM-CSU Trial)

Recruiting at 47 trial locations

Overseen By Danielle Petersel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Escient Pharmaceuticals, Inc

Must be taking: H1 antihistamines

Disqualifiers: Chronic inducible urticaria, atopic dermatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

113 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

Will I have to stop taking my current medications?

The trial requires that participants stay on a stable dose of H1 antihistamine, so you will not have to stop taking this medication.

What data supports the effectiveness of the drug EP262 for treating chronic hives?

The study on the antihistamine BW 825C showed it was highly effective in controlling symptoms of chronic urticaria (hives) compared to a placebo. Additionally, loratadine, another antihistamine, was effective in reducing symptoms like redness and itching in patients with chronic urticaria. ^{1 2 3 4 5}

What makes the treatment EP262 unique for chronic hives?

EP262 is unique because it uses enzyme-potentiated desensitization (EPD), a method that involves very low doses of allergens combined with an enzyme to reduce allergic reactions, which is different from conventional treatments that often use higher doses and can have more side effects. ^{1 3 6 7 8}

Eligibility Criteria

This trial is for people with chronic spontaneous urticaria (CSU), also known as hives, who still have symptoms despite taking up to four times the normal dose of H1 antihistamines. Participants must have a documented history of CSU and a UAS7 score of 16 or higher.

Inclusion Criteria

I am taking a stable dose of an H1 antihistamine, up to four times the normal amount.

I have chronic hives with a UAS7 score of 16 or more, despite taking antihistamines.

Exclusion Criteria

I have a skin condition that causes long-term itching.

You have hives with a known cause other than chronic spontaneous urticaria.

You have hives that are caused by a specific trigger.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EP262 or placebo for chronic spontaneous urticaria

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EP262
• Placebo

Trial Overview The study is testing EP262, an oral medication, against a placebo to see if it can help with CSU. It's conducted across multiple centers where participants are randomly assigned to receive either EP262 or a placebo without knowing which one they're getting.

Participant Groups

Group I: EP262 50 mg Experimental Treatment 1 Intervention

Group II: EP262 25 mg Experimental Treatment 1 Intervention

Group III: EP262 150 mg Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

EP262 is already approved in United States for the following indications:

Approved in United States as EP262 for:

• None approved yet; under investigation for chronic spontaneous urticaria, chronic inducible urticaria, and atopic dermatitis

Who Is Running the Clinical Trial?

Escient Pharmaceuticals, Inc

Lead Sponsor

Trials

6

Recruited

340+

Findings from Research

In a study of 360 patients with perennial allergic rhinitis, a 0.125% cetirizine nasal spray significantly improved symptoms compared to placebo, with a clinically meaningful difference in the percentage of days with no or mild symptoms (30.8% vs. 16.7%, P = 0.011).

The safety profile was similar across all treatment groups, with no significant differences in adverse events, indicating that the 0.125% concentration is both effective and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-ranging, placebo-controlled study of cetirizine nasal spray in adults with perennial allergic rhinitis. Clement, P., Roovers, MH., Francillon, C., et al.[2019]

In a real-life clinical analysis of 51 chronic urticaria patients, omalizumab demonstrated high efficacy, achieving complete remission in 83% of patients with chronic spontaneous urticaria (CSU) and 70% with chronic inducible urticaria (CindU).

Omalizumab was found to be safe, with rapid symptom relief occurring within the first week for 57% of CSU patients, and the treatment's effectiveness was not influenced by baseline IgE levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. Metz, M., Ohanyan, T., Church, MK., et al.[2022]

In a study involving 20 patients with chronic idiopathic urticaria, both doses of BW 825C (4 mg and 8 mg) were found to be highly effective in controlling symptoms compared to placebo.

The treatment was well-tolerated, with few adverse reactions reported, and no significant increase in drowsiness or other side effects compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of the novel antihistamine BW 825C in the treatment of chronic idiopathic urticaria. A placebo-controlled study. Gibson, JR., Harvey, SG., Barth, JH., et al.[2019]

A systematic review of 23 clinical trials involving 2480 participants from 22 countries found a significant increase in the number of new pharmacological treatments, particularly biologics, for H1-antihistamine-refractory chronic spontaneous urticaria (CSU).

The review highlighted disparities in trial representation, with underrepresentation of minority groups and populations from lower-income countries, and noted that less than half of the trials reported patient perspectives, indicating a need for improved trial design and standardized outcome reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives. Nochaiwong, S., Chuamanochan, M., Ruengorn, C., et al.[2022]

In a study of 31 patients with chronic urticaria, loratadine (10 mg daily for 28 days) significantly reduced symptoms like erythema, wheals, and prurigo in 71% of patients, compared to no improvement in the placebo group.

The treatment also led to a marked reduction in skin reactions to histamine, indicating loratadine's efficacy in managing chronic urticaria symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of treatment with loratadine in patients with chronic urticaria]. Siergiejko, Z., Chyrek-Borowska, S.[2015]

Enzyme-potentiated desensitization (EPD) is a promising new method for treating otolaryngic allergies, showing effectiveness in a preliminary study involving 36 patients since February 1997.

EPD addresses various allergic conditions, including allergic rhinitis and asthma, and offers advantages over traditional allergy treatments, suggesting it could be a valuable alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzyme-potentiated desensitization in otolaryngic allergy. Pulec, JL.[2006]

A double-blind placebo-controlled trial involving 20 patients showed that enzyme-potentiated desensitization (EPD) significantly reduced allergy symptoms related to Parietaria and grass pollen compared to placebo, indicating its clinical efficacy in treating pollinosis.

EPD treatment led to beneficial immunological changes, such as an increase in T-CD8+ cells and a decrease in specific IgE levels, suggesting that EPD may enhance the body's tolerance to allergens with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial. Astarita, C., Scala, G., Sproviero, S., et al.[2013]

A single dose of EPD immunotherapy administered 6-8 weeks before the pollen season significantly reduced the need for oral antihistamines in patients with seasonal rhinitis, indicating its efficacy in managing allergy symptoms.

While EPD did not show a significant improvement in rhinoconjunctivitis scores compared to placebo, the overall safety profile was good, suggesting it may be effective for short-term prevention of seasonal allergy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive symptomatic immunotherapy versus placebo in seasonal rhinitis due to grasses in children and to Parietaria in adult patients. Troise, C., Bignardi, D., Modena, P., et al.[2006]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Dose-ranging, placebo-controlled study of cetirizine nasal spray in adults with perennial allergic rhinitis. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An assessment of the novel antihistamine BW 825C in the treatment of chronic idiopathic urticaria. A placebo-controlled study. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

[Results of treatment with loratadine in patients with chronic urticaria]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Enzyme-potentiated desensitization in otolaryngic allergy. [2006]

7. Spain pubmed.ncbi.nlm.nih.gov

Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial. [2013]

8. France pubmed.ncbi.nlm.nih.gov

Preventive symptomatic immunotherapy versus placebo in seasonal rhinitis due to grasses in children and to Parietaria in adult patients. [2006]