Cholinergic UrticariaPhase 2NCT04853992
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
A Phase 2 study testing LEO 152020 in people with Cholinergic Urticaria, run by JW Pharmaceutical at 6 sites in Germany.
Trial summary
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholinergic Urticaria
- What is being tested?
- LEO 152020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 6 sitesGermany
- Study dates
- 10 May 2021to 11 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Subject with a history of Cholinergic urticaria diagnosis for ≥ 6 months
- Subject has active and uncontrolled Cholinergic urticaria disease at the time of screening and randomisation, as defined by the following:
- Urticaria control test < 12 at screening
- Urticaria Activity Score post-provocation ≥ 3
- Recent history (within 6 months of screening) with documented inadequate response to standard dose as to marketing authorization of H1 antihistamines.
Main Exclusion Criteria:
- Other clearly dominating forms* of urticaria as aetiology for wheal and flare type reactions *These diseases are allowed as comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria,
- Systemic immunosuppressive medications within 4 weeks prior to screening,
- Systemic drugs (e.g. oral drug) with antihistamine properties including H1 antihistamines and some antidepressants (e.g. tricyclic antidepressants) and H2 antihistamines 1 week prior to randomisation and throughout the trial. However, topical antihistamines in the form of nasal spray and eyedrops are allowed in the standard prescribed dose.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
LEO Investigational Site
Aachen, 52074
LEO Investigational Site
Berlin, 10117
LEO Investigational Site
Dresden, 01307
LEO Investigational Site
Freiburg im Breisgau, 79104
LEO Investigational Site
Kiel, 24105
LEO Investigational Site
München, 80802
About this study
Official title: Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
Read the detailed description
This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication.
The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.
- Conditions
- Cholinergic Urticaria
- Being tested
- LEO 152020, LEO 152020 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 152020Drug
LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placeboDrug
LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
| Study group | Role | What they receive |
|---|---|---|
| Active - Placebo | Experimental | Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days Receives: Drug: LEO 152020; Drug: LEO 152020 placebo |
| Placebo - Active | Experimental | Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days Receives: Drug: LEO 152020; Drug: LEO 152020 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
Measured: Baseline to Day 7
Secondary outcomes (1)
Number of Treatment Emergent Adverse Events
Measured: From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 May 2021
- Primary completion8 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholinergic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each treatment period will last 7 days with a wash-out period of 7 days between treatments
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853992
- Sponsor's protocol ID
- EXP-2177
- Other IDs
- 2020-004961-38
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2021
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Grekowitz E, Metz M, Altrichter S, Bauer A, Brockow K, Heine G, Lionnet L, Saday KK, Hultsch T, Soerensen OE, Maurer M. Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial. Br J Dermatol. 2024 May 17;190(6):825-835. doi: 10.1093/bjd/ljae038.
PubMed 38308655
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
- ClinicalTrials.gov ID
- NCT04853992
- Acronym / sponsor ID
- EXP-2177
- Conditions
- Cholinergic Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Study start
- 10 May 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
Detailed description
This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication.
The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each treatment period will last 7 days with a wash-out period of 7 days between treatments
| Arm | Type | Receives |
|---|---|---|
| Active - Placebo | Experimental | Drug: LEO 152020, Drug: LEO 152020 placeboPatients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days |
| Placebo - Active | Experimental | Drug: LEO 152020, Drug: LEO 152020 placeboPatients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| LEO 152020LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration. | Drug | Active - Placebo, Placebo - Active |
| LEO 152020 placeboLEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020. | Drug | Active - Placebo, Placebo - Active |
Primary outcome
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
Time frame: Baseline to Day 7
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
1 secondary outcome
Number of Treatment Emergent Adverse Events
Time frame: From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38308655Grekowitz E, Metz M, Altrichter S, Bauer A, Brockow K, Heine G, Lionnet L, Saday KK, Hultsch T, Soerensen OE, Maurer M. Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial. Br J Dermatol. 2024 May 17;190(6):825-835. doi: 10.1093/bjd/ljae038.
- Individual participant dataSharing planned: Yes
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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.
Medical Expert study director
LEO Pharma
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 152020 in people with Cholinergic Urticaria, run by JW Pharmaceutical at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo) (time frame: Baseline to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853992, which also lists 1 linked publication.
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 22 Apr 2024.