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
- 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.
- 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
Name Time Method <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
Name Time Method <p>N/A</p><br>