Chronic Inducible UrticariaPhase 1CALM-CIndUNCT06050928
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
A Phase 1 study testing Oral EP262 in people with Chronic Inducible Urticaria, run by Escient Pharmaceuticals, Inc at 15 sites in 5 countries.
Trial summary
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Inducible Urticaria
- What is being tested?
- Oral EP262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 30 Aug 2023to 22 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
- Willing to discontinue chronic treatment with antihistamines during the study
Who cannot join
- Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria
- Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
- Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Treasure Valley Medical Research
Boise, Idaho, 83706
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
National Allergy and Asthma Research, LLC.
North Charleston, South Carolina, 29420
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Advanced Clinical Research Institute
Tampa, Florida, 33607
Germany3 sites
Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
Berlin, 12203
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 01307
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Canada2 sites
Innovaderm Research Inc.
Montreal, H2X 2V1
Gordon Sussman Clinical Research Inc.
North York, M3B 3S6
Spain2 sites
Hospital del Mar
Barcelona, 08003
Hospital Arnau de Vilanova
Valencia, 46015
Netherlands1 site
Centre for Human Drug Research (CHDR)
Leiden, South Holland, 2333 CL
About this study
Official title: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.
- Conditions
- Chronic Inducible Urticaria
- Being tested
- Oral EP262
- Medical subject headings
- Chronic Inducible Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral EP262Drug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| EP262 150 mg | Experimental | Once daily Receives: Drug: Oral EP262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of EP262
Assessed by the incidence of treatment-emergent adverse events
Measured: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Secondary outcomes (2)
Change in Critical Friction Threshold (CFT)
Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism)
Measured: Measured from Baseline to Week 4
Change in Critical Temperature Threshold (CTT)
Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)
Measured: Measured from Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start30 Aug 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inducible UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escient Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050928
- Sponsor's protocol ID
- EP-262-102
- Acronym
- CALM-CIndU
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
- ClinicalTrials.gov ID
- NCT06050928
- Acronym / sponsor ID
- CALM-CIndU / EP-262-102
- Conditions
- Chronic Inducible Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Escient Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP262 150 mg | Experimental | Drug: Oral EP262Once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
- Willing to discontinue chronic treatment with antihistamines during the study
Key exclusion criteria (3 listed)
- Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria
- Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
- Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral EP262Once daily | Drug | EP262 150 mg |
Primary outcome
Safety and tolerability of EP262
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Assessed by the incidence of treatment-emergent adverse events
2 secondary outcomes
Change in Critical Friction Threshold (CFT)
Time frame: Measured from Baseline to Week 4
Change in Critical Temperature Threshold (CTT)
Time frame: Measured from Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Related trials for Chronic Inducible Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 2
Apremilast Added to Antihistamines in Chronic Urticaria
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Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
RecruitingObservational study
Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral EP262 in people with Chronic Inducible Urticaria, run by Escient Pharmaceuticals, Inc at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Canada, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of EP262 (time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.