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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
History of Changes
  Purpose

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 Intervention Phase
Allergic Contact Dermatitis
 Drug: Placebo
Drug: NI-0801
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Official Title: A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis

Further study details as provided by NovImmune SA:

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

Enrollment: 22
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
single i.v. administration
Experimental: NI-0801 Drug: NI-0801
single i.v. administration

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01244607     History of Changes
Other Study ID Numbers: NI-0801-02
Study First Received: November 16, 2010
Last Updated: November 18, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on May 19, 2013