Allergic Contact DermatitisPhase 3NCT05498467
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
A Phase 3 study testing Anakinra and Sodium Chloride 9mg/ml Injection in people with Allergic Contact Dermatitis, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Anakinra and Sodium Chloride 9mg/ml Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2022to 1 Aug 2024
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged at least eighteen years old.
- Able to provide written informed consent.
- Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
- ICDRG scoring system when challenged with nickel.
- Fitzpatrick skin type 1-4.
- Able to speak and understand Danish.
Who cannot join
- Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0.
- Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0.
- Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
- Dermatitis and/or infection.
- Recent (3 months or less) administration of a live virus vaccine.
- Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating.
Show all 10Show fewer
- Taking part in any other intervention study.
- Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use).
- Presence of any condition or use of any medication which precludes the use of the study drug.
- Allergy to any of the ingredients in the drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Anakinra, Sodium Chloride 9mg/ml Injection
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
100 mg Anakinra injections s.c.
Sodium Chloride 9mg/ml InjectionDrug
9 mg Sodium Chloride injections s.c.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Active comparator | Not described Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium Chloride 9mg/ml Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Reaction
Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start11 Oct 2022
- Primary completion1 Dec 2023
- Study completion1 Aug 2024
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.
- Other trials for Allergic Contact DermatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin Yeung, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498467
- Sponsor's protocol ID
- LEOSIC
- Status last verified
- May 2025
- First submitted
- 8 Aug 2022
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo
- ClinicalTrials.gov ID
- NCT05498467
- Acronym / sponsor ID
- LEOSIC
- Conditions
- Allergic Contact Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Active comparator | Drug: Anakinra |
| Placebo | Placebo comparator | Drug: Sodium Chloride 9mg/ml Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged at least eighteen years old.
- Able to provide written informed consent.
- Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
- ICDRG scoring system when challenged with nickel.
- Fitzpatrick skin type 1-4.
Key exclusion criteria (10 listed)
- Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0.
- Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0.
- Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
- Dermatitis and/or infection.
- Recent (3 months or less) administration of a live virus vaccine.
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 |
|---|---|---|
| Anakinra100 mg Anakinra injections s.c. | Drug | Anakinra |
| Sodium Chloride 9mg/ml Injection9 mg Sodium Chloride injections s.c. | Drug | Placebo |
Primary outcome
Clinical Reaction
Time frame: 2 months
Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anakinra and Sodium Chloride 9mg/ml Injection in people with Allergic Contact Dermatitis, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 6 inclusion and 10 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 May 2025). 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?
Clinical Reaction (time frame: 2 months). 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 20 May 2025.