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

Tracking Information
First Received Date ^ICMJE	November 16, 2010
Last Updated Date	November 18, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2010)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01244607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 18, 2010)	Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	NI-0801 in Allergic Contact Dermatitis
Official Title ^ICMJE	A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study
Condition ^ICMJE	Allergic Contact Dermatitis
Intervention ^ICMJE	Drug: Placebo single i.v. administration Drug: NI-0801 single i.v. administration
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Experimental: NI-0801 Intervention: Drug: NI-0801
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01244607
Other Study ID Numbers ^ICMJE	NI-0801-02
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	NovImmune SA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NovImmune SA
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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