Phase
Condition
Scar Tissue
Treatment
Belimumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants with SSc-ILD that have completed Study 218224 through to and includingthe Week 52 visit and are not considered treatment failure, defined as meetingeither of the following criteria:
Initiation of new immunosuppressive or immunomodulatory medication forSSc-related disease activity/progression since joining study 218224.
Discontinuation of study medication during study 218224 for any reason.
Participant has an area of uninvolved or mildly thickened skin that, in the opinionof the investigator, would allow subcutaneous (SC) injection at the abdomen or thefront, middle region of the thigh.
Participant is capable and willing to self-administer the study medication or has acaregiver/healthcare professional who is capable and willing to administer the studymedication throughout the study.
Female participants: A female participant is eligible to participate if she is notpregnant or breastfeeding, and one of the following conditions applies:
Is a woman of non-childbearing potential (WONCBP) or Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, asrequired by local regulations) within 24 hours before the first dose of studyintervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), serumpregnancy test is required. In such cases, the participant must be excluded fromparticipation if the serum pregnancy result is positive.
Additional requirements for pregnancy testing during and after study interventionare located.
The investigator is responsible for review of medical history, menstrual history,and recent sexual activity to decrease the risk for inclusion of a woman with anearly undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and inthe protocol.
Exclusion
Exclusion Criteria:
- Participants of Study 218224 who have discontinued study treatment, prior to Week
Participants who have developed clinical evidence of significant, unstable oruncontrolled, acute or chronic diseases not due to SSc (i.e, cardiovascular,pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancyor infectious diseases), or experienced an AE in Study 218224 that could, in theopinion of the principal investigator, put the participant at undue risk.
Participants who have developed any other medical diseases (eg, cardiopulmonary),laboratory abnormalities, or conditions (eg, poor venous access) that, in theopinion of the investigator could significantly alter the absorption, metabolism, orelimination of drugs; constitutes a risk when taking the study intervention;interferes with the interpretation of data; or it is not safe for the participant tocontinue on the study.
Participants who have been exposed to ionizing radiation in excess of 10millisievert (mSv) above background over the previous 3 year period as a result ofoccupational exposure or previous participation in research studies.
QT Interval Corrected (QTc) greater than (>) 480 millisecond (msec) at Week 52 ofparent study 218224 (Day 1 of 219855).
Study Design
Connect with a study center
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, 1425
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires,
ArgentinaSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
LiEge, 4000
BelgiumSite Not Available
GSK Investigational Site
Belo Horizonte, 30150221
BrazilSite Not Available
GSK Investigational Site
Curitiba, 80440-080
BrazilSite Not Available
GSK Investigational Site
Juiz de Fora, 36010-570
BrazilSite Not Available
GSK Investigational Site
Porto Alegre,
BrazilSite Not Available
GSK Investigational Site
SAo Paulo, 04038-002
BrazilSite Not Available
GSK Investigational Site
Salvador, 40.150-150
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 01308-050
BrazilSite Not Available
GSK Investigational Site
Beijing, 100730
ChinaSite Not Available
GSK Investigational Site
Changchun, 130021
ChinaSite Not Available
GSK Investigational Site
Chengdu, 610041
ChinaSite Not Available
GSK Investigational Site
Luzhou, 648000
ChinaSite Not Available
GSK Investigational Site
Mianyang,
ChinaSite Not Available
GSK Investigational Site
Nanjing, 210008
ChinaSite Not Available
GSK Investigational Site
Nanning, 530000
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200001
ChinaSite Not Available
GSK Investigational Site
Shenyang, 110001
ChinaSite Not Available
GSK Investigational Site
ZhuZhou, 412007
ChinaSite Not Available
GSK Investigational Site
Aarhus, 8200
DenmarkSite Not Available
GSK Investigational Site
Odense C, 5000
DenmarkSite Not Available
GSK Investigational Site
Turku, 20520
FinlandSite Not Available
GSK Investigational Site
Bobigny cedex, 93000
FranceSite Not Available
GSK Investigational Site
Bad Bentheim, 48455
GermanySite Not Available
GSK Investigational Site
Duesseldorf, 40225
GermanySite Not Available
GSK Investigational Site
Koeln, 51149
GermanySite Not Available
GSK Investigational Site
Mainz, 55131
GermanySite Not Available
GSK Investigational Site
Minden, 32429
GermanySite Not Available
GSK Investigational Site
Tuebingen, 72076
GermanySite Not Available
GSK Investigational Site
Athens, 12462
GreeceSite Not Available
GSK Investigational Site
Heraklion Crete, 71110
GreeceSite Not Available
GSK Investigational Site
Larissa, 41110
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 546 42
GreeceSite Not Available
GSK Investigational Site
Haifa, 3436212
IsraelSite Not Available
GSK Investigational Site
Holon, 58100
IsraelSite Not Available
GSK Investigational Site
Kfar Saba, 44281
IsraelSite Not Available
GSK Investigational Site
Poriya, 15208
IsraelSite Not Available
GSK Investigational Site
Tel Aviv, 64239
IsraelSite Not Available
GSK Investigational Site
Tel Hashomer, 52621
IsraelSite Not Available
GSK Investigational Site
Ancona,
ItalySite Not Available
GSK Investigational Site
Bari,
ItalySite Not Available
GSK Investigational Site
Cagliari, 09042
ItalySite Not Available
GSK Investigational Site
Catania,
ItalySite Not Available
GSK Investigational Site
Ferrara,
ItalySite Not Available
GSK Investigational Site
Firenze, 50134
ItalySite Not Available
GSK Investigational Site
Milano,
ItalySite Not Available
GSK Investigational Site
Modena, 41124
ItalySite Not Available
GSK Investigational Site
Napoli, 80131
ItalySite Not Available
GSK Investigational Site
Orbassano TO,
ItalySite Not Available
GSK Investigational Site
Padova,
ItalySite Not Available
GSK Investigational Site
Pavia,
ItalySite Not Available
GSK Investigational Site
Roma,
ItalySite Not Available
GSK Investigational Site
Verona, 37134
ItalySite Not Available
GSK Investigational Site
Seoul, 05505
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon Kyunggi-do, 16499
Korea, Republic ofSite Not Available
GSK Investigational Site
Yongsan-Ku Seoul,
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Chihuahua, 31000
MexicoSite Not Available
GSK Investigational Site
Ciudad de Mexico, 03310
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44650
MexicoSite Not Available
GSK Investigational Site
Merida, CP 97070
MexicoSite Not Available
GSK Investigational Site
Torreon, 27000
MexicoSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
Bilbao, 48013
SpainSite Not Available
GSK Investigational Site
Granada, 18016
SpainSite Not Available
GSK Investigational Site
Madrid, 28046
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
VigoPontevedra, 36200
SpainSite Not Available
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