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

NCT ID: NCT05498467

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2024-08-01

Brief Summary

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

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anakinra

Group Type: ACTIVE_COMPARATOR

Anakinra

Intervention Type: DRUG

100 mg Anakinra injections s.c.

Placebo

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 9mg/ml Injection

Intervention Type: DRUG

9 mg Sodium Chloride injections s.c.

Interventions

Anakinra

100 mg Anakinra injections s.c.

Intervention Type: DRUG

Sodium Chloride 9mg/ml Injection

9 mg Sodium Chloride injections s.c.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kelvin Yeung

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LEOSIC

Identifier Type: -

Identifier Source: org_study_id