NI-0801 in Allergic Contact Dermatitis

• Sponsor: Light Chain Bioscience - Novimmune SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01244607
• Collaborator: (none)
• Enrollment: 22
• Arms: 2

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; single i.v. administration
Experimental: NI-0801	Drug: NI-0801; single i.v. administration

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Light Chain Bioscience - Novimmune SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01244607
• Other Study ID Numbers: NI-0801-02
• First Posted: Nov 19, 2010
• Last Update Posted: Nov 19, 2010
• Last Verified: Nov 1, 2010

• Additional relevant MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact

Study Results

No Results Posted as of Nov 19, 2010