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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
No Changes Posted
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
Not Provided

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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01244607
NI-0801-02
No
Not Provided
Not Provided
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