A study evaluating the safety, tolerability, and efficacy of GLPG5101 in adults with treatment-refractory active systemic lupus erythematosus

2023-504422-19-00 Protocol GLPG5101-CL-104 Human pharmacology (Phase I) - Other Ended

End 22 Feb 2024 · Status Ended · 2 EU/EEA countries · 4 sites · Protocol GLPG5101-CL-104

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 20
Countries 2
Sites 4

Treatment-refractory active systemic lupus erythematosus

Key facts

Sponsor
Galapagos
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20]
Trial duration
completed 22 Feb 2024
Decision date (initial)
2023-10-03
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Treatment-refractory active systemic lupus erythematosus

VersionLevelCodeTermSystem organ class
21.1 PT 10042945 Systemic lupus erythematosus 100000004859

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Galapagos

8 Total trials 1 Recruiting 5 Ended
Commercial
Sponsor organisation
Galapagos
Address
Generaal De Wittelaan L11 A3
City
Mechelen
Postcode
2800
Country
Belgium

Scientific contact point

Organisation
Galapagos
Contact name
Medical Information

Public contact point

Organisation
Galapagos
Contact name
Medical Information

Locations

2 EU/EEA countries · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 10 2
Netherlands Ended 10 2
Rest of world — 0 —

Investigational sites

Belgium

2 sites · Ended
Cliniques Universitaires Saint-Luc
Rheumatology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU De Liege
Rheumatology, Avenue De L'hopital 1, 4000, Liege

Netherlands

2 sites · Ended
Academisch Medisch Centrum
Rheumatology, Meibergdreef 9, 1105 AZ, Amsterdam
Academisch Ziekenhuis Leiden
Rheumatology, Albinusdreef 2, 2333 ZA, Leiden

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-14 Netherlands Acceptable with conditions
2023-10-02
 2023-10-02
2 SUBSTANTIAL MODIFICATION SM-1 2023-11-06 Netherlands Acceptable
2024-02-12
 2024-02-13