NI-0801 in Allergic Contact Dermatitis | NCT01244607

Studies
NI-0801 in Allergic Contact Dermatitis

NCT01244607

Sponsor

Light Chain Bioscience - Novimmune SA

Status

Completed

Last Update Posted

Nov 19, 2010Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Allergic Contact Dermatitis

Interventions

Placebo
NI-0801

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2010

Last Update Posted Date

Nov 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
NI-0801	Experimental		Drug: NI-0801

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	single i.v. administration	Placebo
NI-0801

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017449	Dermatitis, Allergic Contact

Ancestor Terms

ID	Term
D003877	Dermatitis, Contact
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided