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CompletedNCT01244607Updated Nov 19, 2010

NI-0801 in Allergic Contact Dermatitis

A Phase 1 interventional study of Placebo and NI-0801 in Allergic Contact Dermatitis, sponsored by Light Chain Bioscience - Novimmune SA. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-19.

Sponsored by Light Chain Bioscience - Novimmune SA · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Contact Dermatitis
03

In context

Dermatitis, Allergic Contact

52 studies on the registry are indexed under Dermatitis, Allergic Contact; 12 are open to participants now.

This study's enrollment of 22 is below the median of 48 across 40 interventional studies indexed under Dermatitis, Allergic Contact.

Browse Dermatitis, Allergic Contact studies →

Lead sponsor

Light Chain Bioscience - Novimmune SA is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥ 18 and ≤ 70 years
  • Either male or a female lacking childbearing potential
  • Previously documented nickel allergy

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Enrollment
22 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    NI-0801

    Drug: NI-0801

Interventions

  • DrugPlacebo

    single i.v. administration

  • DrugNI-0801

    single i.v. administration

06

What researchers measure

Primary outcomes

  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 outcomes

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01244607
Lead sponsor
Light Chain Bioscience - Novimmune SA
First posted
Nov 19, 2010
Last update
Nov 19, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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