Anti-IL-17 a New Treatment for Contact Dermatititis

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tanja Todberg, MD
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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

• Moderate to severe dermatitis at inclusion (PGA ≥ 3)

• 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

Exclusion Criteria:

• 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

• 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