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

NCT05498467 | Completed Phase 3 Results

• 1 other identifier: LEOSIC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• Clinical Reaction

  Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo

  2 months

Study Arms (2)

Anakinra

ACTIVE COMPARATOR

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

Drug: Sodium Chloride 9mg/ml Injection

Interventions

Anakinra DRUG

100 mg Anakinra injections s.c.

Anakinra

Sodium Chloride 9mg/ml Injection DRUG

9 mg Sodium Chloride injections s.c.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Interleukin 1 Receptor Antagonist Protein; Sodium Chloride

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Kelvin Yeung
• Organization: Department of Dermatology and Allergy - Herlev-Gentofte Hospital

kelvin.yeung@sund.ku.dk

38673243

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: October 11, 2022
• Primary Completion: December 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)