The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis

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

Study Overview

• Status: Completed
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Drug: Anakinra; Drug: Sodium Chloride 9mg/ml Injection

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Sodium Chloride 9mg/ml Injection; 9 mg Sodium Chloride injections s.c.
Active Comparator: Anakinra	Drug: Anakinra; 100 mg Anakinra injections s.c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Reaction	Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo	2 months

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: LEOSIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No