NI-0801 in Allergic 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.

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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

single i.v. administration

NI-0801

Drug

single i.v. administration

Primary outcomes

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 outcomes

Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.

Sponsors and collaborators

Lead sponsor

Light Chain Bioscience - Novimmune SA

Industry

Registry information

Official study title

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

Important dates

First posted: Nov 19, 2010
Registry last updated: Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed