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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014