Anti-IL-17 a New Treatment for Contact Dermatititis

NCT02778711 | Unknown Phase 3 DMC

• 1 other identifier: 2015-004494-33
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of anti-IL 17 treatment (secukinumab) in patients with known severe allergic contact dermatitis (ACD).

Conditions

Allergic Contact Dermatitits

Keywords

anti-IL-17; secukinumab

Outcome Measures

Primary Outcomes (2)

• 1. Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before treatment (study 1)

  18 months

• Reduction in severity of eczema using the PGA score after treatment with secukinumab.

  18 months

Study Arms (1)

Cosentyx

EXPERIMENTAL

secukinumab (anti-IL-17)

Drug: secukinumab

Interventions

secukinumab DRUG

anti-IL-17

Also known as: Cosentyx

Cosentyx

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be \> 18
• Have a known nickel allergy with at least a +2 reaction when challenged with nickel
• Patients must have given their informed consent to the protocol and the clinical procedures
• Be able to speak and understand Danish.
• Patients must be \> 18
• Have at least two known contact allergies
• Failure to local anti-inflammatory treatment and to at least one systemic anti-inflammatory treatment
• Patients must have given their informed consent to the protocol and the clinical procedures
• Be able to speak and understand Danish

You may not qualify if:

• Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
• Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0
• Patients who have received any other study medication 4 weeks prior to day 0
• Dermatitis at the upper inner arm
• Patients with clinically significant disorders
• Patients with active TB/serious infections
• Pregnancy
• Nursing
• Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (\> 12 months of amenorrhea) are allowed not to use contraception.
• Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
• Latex allergy
• Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
• Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0
• Patients who have received any other study medication 4 weeks prior to day 0
• Patients with clinically significant disorders

Sponsors & Collaborators

• Tanja Todberg, MD: lead

Study Sites (1)

Department of Dermato-Allergology

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

secukinumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 20, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

DK (1)