NI-0801 in Allergic Contact Dermatitis

Allergic Contact Dermatitis Clinical Trial

Official title:

A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244607
• Other study ID #: NI-0801-02
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2010
• Last updated: November 18, 2010

Study information

• Verified date: November 2010
• Source: NovImmune SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact
• Eczema

Intervention

Drug:
• Placebo
single i.v. administration
• NI-0801
single i.v. administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NovImmune SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.