EP262 for Chronic Hives
(CALM-CSU Trial)
Recruiting in Palo Alto (17 mi)
+47 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Escient Pharmaceuticals, Inc
Must be taking: H1 antihistamines
Disqualifiers: Chronic inducible urticaria, atopic dermatitis, others
Prior Safety Data
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.
12345What 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.
13678Eligibility 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.
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: EP262 50 mgExperimental Treatment1 Intervention
Group II: EP262 25 mgExperimental Treatment1 Intervention
Group III: EP262 150 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toledo Institute of Clinical Research Inc.Toledo, OH
Allergy and Clinical Immunology AssociatesPittsburgh, PA
Advanced Clinical Research InstituteTampa, FL
Treasure Valley Medical ResearchBoise, ID
More Trial Locations
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Who Is Running the Clinical Trial?
Escient Pharmaceuticals, IncLead Sponsor
References
Dose-ranging, placebo-controlled study of cetirizine nasal spray in adults with perennial allergic rhinitis. [2019]A total of 360 patients with perennial allergic rhinitis were randomized in a placebo-controlled, dose-finding study comparing three concentrations (0.06%, 0.125%, and 0.25%) of a cetirizine nasal spray, administered three times a day for 2 weeks. The primary criterion of efficacy was the percentage of days with no or only mild symptoms of rhinitis (PDMax1), as evaluated by the patients. The median PDMax1 were 16.7%, 30.8%, 42.9%, and 26.7% for the placebo, 0.06%, 0.125%, and 0.25% groups, respectively. Although the global comparison among the four groups only approached statistical significance (P = 0.076), the difference (26.2%) between the placebo and 0.125% groups was clinically and statistically significant (P = 0.011). For the global evaluation by the investigator, the best results were seen in the 0.125% group (P = 0.03). The occurrence of adverse events did not differ among the four treatment groups and consisted mainly of nasal events, occurring in 22.5%, 17.1%, 12.9%, and 24.4% of the patients for the placebo, 0.06%, 0.125%, and 0.25% groups, respectively (P = 0.184). These results indicate that the 0.125% concentration is significantly better than placebo and offers the best therapeutic ratio.
Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. [2022]Omalizumab (anti-IgE) therapy is effective and safe in chronic urticaria (CU) in placebo-controlled clinical trials but real life clinical data are scarce.
An assessment of the novel antihistamine BW 825C in the treatment of chronic idiopathic urticaria. A placebo-controlled study. [2019]20 patients with a diagnosis of chronic idiopathic urticaria were entered into a double-blind placebo-controlled cross-over study. All patients completed the trial and during the assessment period they were treated with placebo, BW 825C (4 mg) and BW 825C (8 mg) according to a fully randomised and balanced treatment plan. Both doses of BW 825C were found to be highly effective and significantly better than placebo in controlling signs and symptoms of urticaria. Few adverse reactions were reported and in this small group of patients there was no significant difference from placebo in reports of drowsiness or any other side-effects.
Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives. [2022]No data addressing issues concerning disparities in participant and trial characteristics and trial outcome reporting have been established in clinical trials for H1-antihistamine-refractory chronic spontaneous urticaria (CSU). To better harmonize and compare the different treatment interventions, we systematically evaluated the overall landscape of pharmacological treatments for H1-antihistamine-refractory CSU clinical trials published between 2000 and 2021. This systematic review included 23 randomized clinical trials involving 2480 participants from 22 countries. We found significant increases in the number of globally published and newly tested drugs, especially biologic drugs. Regarding relatively small trials, we found that people living with H1-antihistamine-refractory CSU who were identified as members of minority groups (non-white population), populations of regions other than North America/Europe, and populations of low- to lower/upper-middle-income countries are underrepresented. Most trials were designed to evaluate treatment efficacy and safety profiles; however, less than half of the included trials reported the patient's perspective in terms of patient-reported outcomes. Disparities in outcome reporting, including clinimetric tools for assessing treatment response and outcome sets, were observed. To close the evidence gap in H1-antihistamine-refractory CSU trials, strategies for improving trial and participant enrollment and standardizing core outcome sets for trial reporting are needed.
[Results of treatment with loratadine in patients with chronic urticaria]. [2015]This study aimed at evaluating loratadine efficiency versus placebo in the treatment of patients with chronic urticaria. The single blind trial involved 31 patients divided into the group treated with active drug (21 patients), and placebo (10 patients). Loratadine in a daily dose of 10 mg (1 tablet in the evening) was administered for 28 days whereas placebo was given for 14 days. Patients filled so-called self-observation charts in which a severity of disease symptoms and/or adverse reactions were noted every day. Skin test with histamine was performed in the hospital before the trial, after 2 weeks, and in the last day of the treatment. The obtained results showed a marked decrease in erythema, wheals, and prurigo in patients treated with loratadine. No such an improvement was seen in placebo group. Skin reaction to histamine was also markedly reduced in loratadine group. Loratadine proved an efficient agent in the treatment of the chronic urticaria in 71% of patients.
Enzyme-potentiated desensitization in otolaryngic allergy. [2006]This is a preliminary report of a new method of treating otolaryngic allergy with enzyme-potentiated desensitization (EPD). The nature of EPD and its use in otolaryngology are described. Thirty-six patients have been treated and followed in a private medical practice since February 1997. This article reviews the clinical features of EPD and provides six cases as examples; the clinical features described include allergic rhinitis, serous otitis media, asthma, dermatitis, fixed food allergy, and Ménière's disease. EPD is an effective technique for the treatment of otolaryngic allergy and offers advantages over conventional techniques.
Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial. [2013]Several controlled clinical trials have shown that specific immunotherapy (SIT) using incremental injections of allergens can be effective in the treatment of allergic rhinitis and asthma. Nevertheless, the risk of side effects have led to some recommended limitations of SIT. Enzyme-potentiated desensitization (EPD) is a proposed method for immunotherapy with very low doses of mixed allergens plus beta-glucuronidase enzyme, for which irrelevant or no side effects have been claimed. The aim of this study was to determine the clinical efficacy of EPD in the treatment of pollinosis. A double-blind placebo-controlled trial of EPD among 20 patients sensitive to Parietaria and grass pollen was performed. All patients recorded daily symptom scores for nine months following a single intradermal injection of EPD or buffered saline received in February. Symptoms recorded were nasal itching and obstruction, sneezing, rhinorrhea, itchy eyes and excessive tear production. Moreover, total and specific lgE were measured and CD3+, CD4+ and CD8+ peripheral blood lymphocytes were counted at different times. In the same period, ten additional subjects, with an allergic clinical profile similar to the subjects admitted to the double-blind trial, were studied in an open clinical trial in order to evaluate the effects of EPD without enzyme using a mixture of allergens. Symptom scores were higher in the placebo group (p
Preventive symptomatic immunotherapy versus placebo in seasonal rhinitis due to grasses in children and to Parietaria in adult patients. [2006]EPD is the only preventive symptomatic immunotherapy available on the market and approved by competent bodies. Recent double-blind placebo controlled (DBPC) studies have demonstrated its efficacy in seasonal and perennial rhinitis. The aim of the study was to confirm the efficacy and safety of a single dose of immunotherapy administered six-eight weeks before the pollen season.