NI-0801 in Allergic Contact Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244607
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Drug: Placebo Drug: NI-0801 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Official Title: A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
single i.v. administration

Experimental: NI-0801 Drug: NI-0801
single i.v. administration

Primary Outcome Measures :
  1. 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 :
  1. Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 Identifier: NCT01244607     History of Changes
Other Study ID Numbers: NI-0801-02
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases