NI-0801 in Allergic Contact Dermatitis
- Registration Number
- NCT01244607
- Lead Sponsor
- Light Chain Bioscience - Novimmune SA
- Brief Summary
The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Aged ≥ 18 and ≤ 70 years
- Either male or a female lacking childbearing potential
- Previously documented nickel allergy
Exclusion Criteria
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
- Known or previous diagnosis of malignancy
- Known current active tuberculosis or a history of active TB within 12 months of screening
- Known infection with HIV, Hepatitis B or C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo - NI-0801 NI-0801 -
- Primary Outcome Measures
Name Time Method Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).
- Secondary Outcome Measures
Name Time Method Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.