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A controlled in vitro hypersensitivity assessment in subjects previously treated whit the combination of GLPG3067 and GLPG2222, or the combination of GLPG3067, GLPG222 and GLPG2737 using Lymphocyte Transformation Test.

Conditions
Skin reaction (e.g. rash)
10014982
Registration Number
NL-OMON45940
Lead Sponsor
Galapagos N.V.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
2
Inclusion Criteria

- trial subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067 -CL -101 or the GLPG3067-CL-108 clinical trial and developed skin reactions suspected as drug hypersensitivity, OR
-control subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067- CL- 101 or the GLPG3067-CL-108 clinical trial and did not develop any skin reaction or drug hypersensitivity signs.;- Able and willing to comply with the protocol requirements and to sign the ICF as approved by the Independent Ethics Committee (IEC), before any study-related procedures are performed.

Exclusion Criteria

- Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>For this follow-up study, blood will be collected and this blood will be used<br /><br>for a so called lymphocyte transformation test (LTT). The LTT is a useful test<br /><br>for the diagnosis of drug hypersensitivity. The LTT will be done in order to<br /><br>better understand the cause of these hypersensitivity skin reactions.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>N/A</p><br>
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