EP262 for Chronic Urticaria

(CALM-CIndU Trial)

No longer recruiting at 16 trial locations

Overseen By Escient Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Escient Pharmaceuticals, Inc

Must not be taking: Antihistamines

Disqualifiers: Atopic dermatitis, Bullous pemphigoid, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EP262 for people with Chronic Inducible Urticaria (CIndU), a condition where the skin reacts to stimuli like scratching or cold temperatures. The trial aims to assess the safety and effectiveness of EP262 for those with symptoms such as itchy welts from skin contact or exposure to cold. Participants must have had CIndU for more than three months and be willing to stop taking antihistamines during the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

You will need to stop taking chronic antihistamines during the study.

Is there any evidence suggesting that EP262 is likely to be safe for humans?

Research has shown that EP262 is generally safe for people. An earlier study found EP262 to be safe and well-tolerated at all doses tested, with most participants experiencing no serious side effects. In fact, no serious side effects were reported. This is encouraging for those considering joining the trial. The treatment was tested at doses much higher than necessary for effectiveness, further supporting its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for chronic urticaria, which often includes antihistamines and corticosteroids, EP262 is unique because it is an experimental treatment that may work through a novel mechanism. Researchers are excited about EP262 because it targets specific pathways involved in the inflammatory response, potentially offering relief with once-daily dosing. This could mean fewer side effects and improved effectiveness compared to current treatments, making it a promising option for patients who do not respond well to existing therapies.

What evidence suggests that EP262 might be an effective treatment for chronic urticaria?

Research has shown that EP262, which participants in this trial will receive, could be a promising treatment for chronic hives. Early studies suggest that EP262 might help people with chronic inducible hives handle more triggers before symptoms appear. This means patients may experience fewer symptoms even when exposed to usual triggers. Tests on healthy individuals found the drug to be safe, with no serious side effects. While more research is needed, these early results suggest EP262 could help manage chronic hives symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Inducible Urticaria (CIndU), specifically those who have had symptomatic dermographism or cold urticaria for more than three months. Participants must respond positively to skin tests and are willing to stop taking antihistamines during the study. People with other underlying causes of hives or active skin diseases that could affect results, or those who regularly have extensive wheals where testing occurs, cannot join.

Inclusion Criteria

I have been diagnosed with chronic inducible urticaria for over 3 months and responded positively to skin tests.

I am willing to stop taking antihistamines for the study.

Exclusion Criteria

You have hives, but they are not caused by rubbing your skin or exposure to cold.

I do not have other skin conditions that could affect the study's results.

You often get large rashes in the area where the skin test will be done.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EP262 150 mg once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EP262

Trial Overview The trial is testing an oral medication called EP262 on people with CIndU to see how safe it is and how it affects their condition. It's in Phase 1b, which means they're still early in studying this drug's effects on humans after initial safety has been assessed.

How Is the Trial Designed?

Group I: EP262 150 mg Experimental Treatment 1 Intervention

Once daily

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+

Published Research Related to This Trial

The updated international guidelines for treating chronic urticaria recommend a three-step approach starting with a standard dose of non-sedating H1 antihistamines, which can be increased if necessary.

For patients who do not respond to initial treatments, the guidelines suggest using omalizumab, cyclosporine A, or montelukast, while short-term corticosteroids may be considered for up to 10 days, reflecting a shift in treatment strategies based on the latest evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisions to the international guidelines on the diagnosis and therapy of chronic urticaria. Maurer, M., Magerl, M., Metz, M., et al.[2022]

Citations

1. escientpharma.com escientpharma.com/escient-pharmaceuticals-announces-positive-results-from-phase-1-study-of-ep262-a-first-in-class-oral-mrgprx2-antagonist-for-mast-cell-mediated-disorders/

Press Releases In the Phase 1 study, which enrolled 64 healthy volunteers, EP262 was safe and well-tolerated at all doses tested, with no serious or severe ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06077773

Study Details | NCT06077773 | Phase 2, Multicenter, ... Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with ...

3. withpower.com withpower.com/trial/phase-2-urticaria-9-2023-f6cbb

EP262 for Chronic Hives (CALM-CSU Trial) The study on the antihistamine BW 825C showed it was highly effective in controlling symptoms of chronic urticaria (hives) compared to a placebo. Additionally, ...

4. annallergy.org annallergy.org/article/S1081-1206(24)00343-0/fulltext

The future of targeted therapy in chronic spontaneous ... A meta-analysis found that the rate of response in patients with CSU who responded to updosing was 63.2%. Therefore, approximately 40% of ...

5. clinicaltrials.eu clinicaltrials.eu/inn/ep262/

Ep262 – Application in Therapy and Current Clinical ... In cases of chronic inducible urticaria, EP262 might help increase the threshold at which symptoms appear. This means that patients may be able to tolerate more ...

6. escientpharma.com escientpharma.com/escient-pharmaceuticals-initiates-clinical-proof-of-concept-study-of-ep262-a-first-in-class-oral-mrgprx2-antagonist-in-chronic-spontaneous-urticaria/

Press Releases Efficacy and safety of EP262 to be assessed in a randomized, placebo-controlled study in ~90 patients; Second of three clinical ...

7. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-acquisition-escient-pharmaceuticals-and-its

Incyte Announces Acquisition of Escient Pharmaceuticals ... Preclinical data demonstrate that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell- ...

8. rarediseaseadvisor.com rarediseaseadvisor.com/news/phase-1-study-ep262-demonstrates-high-safety/

Phase 1 Study of EP262 Demonstrates High Safety ... According to the results, the experimental drug was safe and well-tolerated at all doses. There were no serious or severe adverse events, no ...