NI-0801 in Allergic Contact Dermatitis

This study has been completed.
Sponsor:
Information provided by:
NovImmune SA
ClinicalTrials.gov Identifier:
NCT01244607
First received: November 16, 2010
Last updated: November 18, 2010
Last verified: November 2010

November 16, 2010
November 18, 2010
Not Provided
Not Provided
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).
Same as current
Complete list of historical versions of study NCT01244607 on ClinicalTrials.gov Archive Site
Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.
Same as current
Not Provided
Not Provided
 
NI-0801 in Allergic Contact Dermatitis
A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Allergic Contact Dermatitis
  • Drug: Placebo
    single i.v. administration
  • Drug: NI-0801
    single i.v. administration
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: NI-0801
    Intervention: Drug: NI-0801
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
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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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01244607
NI-0801-02
No
Not Provided
NovImmune SA
Not Provided
Not Provided
NovImmune SA
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP