Allergic Contact DermatitisPhase 1NCT01244607
NI-0801 in Allergic Contact Dermatitis
A Phase 1 study testing NI-0801 in people with Allergic Contact Dermatitis, run by Light Chain Bioscience - Novimmune SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- NI-0801
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 and ≤ 70 years
- Either male or a female lacking childbearing potential
- Previously documented nickel allergy
Who cannot join
- 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
About this study
Official title: A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced 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.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Placebo, NI-0801
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
single i.v. administration
NI-0801Drug
single i.v. administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| NI-0801 | Experimental | Not described Receives: Drug: NI-0801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Chain Bioscience - Novimmune SA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244607
- Sponsor's protocol ID
- NI-0801-02
- Status last verified
- Nov 2010
- First submitted
- 16 Nov 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis
- ClinicalTrials.gov ID
- NCT01244607
- Acronym / sponsor ID
- NI-0801-02
- Conditions
- Allergic Contact Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Light Chain Bioscience - Novimmune SAIndustry (pharma, biotech, devices)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| NI-0801 | Experimental | Drug: NI-0801 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18 and ≤ 70 years
- Either male or a female lacking childbearing potential
- Previously documented nickel allergy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebosingle i.v. administration | Drug | Placebo |
| NI-0801single i.v. administration | Drug | NI-0801 |
Primary outcome
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).
1 secondary outcome
Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NI-0801 in people with Allergic Contact Dermatitis, run by Light Chain Bioscience - Novimmune SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.