Phase
Condition
Collagen Vascular Diseases
Scleroderma
Scar Tissue
Treatment
Anifrolumab (blinded)
Anifrolumab (unblinded, open label)
Anifrolumab (blinded)
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Adult patients from 18 to 70 years of age inclusive
Systemic sclerosis according to 2013 ACR/EULAR classification criteria
Limited or diffuse cutaneous subsets
Systemic sclerosis disease duration within 6 years from first non-Raynaud'sphenomenon manifestation at the time of signing the ICF
Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
mRSS > 10 with early disease or rapid progression as defined by the protocol
mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by theprotocol
Stable background therapies can be used including hydroxychloroquine, methotrexate,azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oralglucocorticoids or tacrolimus
Women of childbearing potential with a negative urine pregnancy test
Uninvolved skin at injection sites
Exclusion
Key Exclusion Criteria:
Anticentromere antibody seropositivity on central laboratory
Severe cardiopulmonary disease as defined by the protocol
History of systemic sclerosis renal crisis within past 12 months (estimatedglomerular filtration rate(eGFR) < 45 mL/min/1.73m2)
Overlap syndromes, systemic lupus erythematosus with anti-double-strandeddeoxyribonucleic acid antibody seropositivity or anti-citrullinated proteinantibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema,eosinophilic fasciitis)
History of, or current, any other inflammatory diseases, eg, inflammatory boweldisease, skin disease, that, in the opinion of the investigator, could interferewith efficacy and safety assessments or require immunomodulatory therapy
Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), orgastrointestinal disease (eg, clinical signs of malabsorption or needing parenteralnutrition) not related to SSc, as determined by the investigator
Hematopoietic stem cell transplantation or solid organ/limb transplantation
Any severe case of Herpes Zoster infection as defined by the protocol
Known malignancy or a history of malignancy within 5 years, with exception ofexcised/cured local basal or squamous cell carcinoma of the skin or carcinoma insitu of the uterine cervix
Major surgery within 8 weeks prior to and/or during study enrollment
Known active current or history of recurrent infections
Any condition that, in the opinion of the investigator or AstraZeneca, wouldinterfere with the efficacy or safety evaluation of the study intervention or putparticipant at safety risk
Study Design
Study Description
Connect with a study center
Research Site
Graz, 8036
AustriaActive - Recruiting
Research Site
Innsbruck, 6020
AustriaActive - Recruiting
Research Site
Linz, 4020
AustriaActive - Recruiting
Research Site
Wien, 1090
AustriaActive - Recruiting
Research Site
Brussels, 1070
BelgiumSite Not Available
Research Site
Gent, B-9000
BelgiumActive - Recruiting
Research Site
Leuven, 3000
BelgiumActive - Recruiting
Research Site
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
Research Site
Edmonton, Alberta T6G 2R7
CanadaSite Not Available
Research Site
Vancouver, British Columbia 5Z 1L7
CanadaSite Not Available
Research Site
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Research Site
Toronto, Ontario M5T 3L9
CanadaSite Not Available
Research Site
Montreal, Quebec H4J 1C5
CanadaActive - Recruiting
Research Site
Quebec, G1V 3M7
CanadaActive - Recruiting
Research Site
Beijing, CN-100730
ChinaActive - Recruiting
Research Site
Chengdu, 610041
ChinaSite Not Available
Research Site
Guangzhou, 510530
ChinaActive - Recruiting
Research Site
Hangzhou, 310014
ChinaActive - Recruiting
Research Site
Lanzhou, 730000
ChinaActive - Recruiting
Research Site
Shanghai, 200032
ChinaActive - Recruiting
Research Site
Tianjin, 300050
ChinaActive - Recruiting
Research Site
Wuhan, 430022
ChinaSite Not Available
Research Site
Bordeaux Cedex, 33076
FranceActive - Recruiting
Research Site
Brest Cedex, 29609
FranceActive - Recruiting
Research Site
La Tronche, 38043
FranceActive - Recruiting
Research Site
Paris, 75679
FranceActive - Recruiting
Research Site
Reims, 51092
FranceActive - Recruiting
Research Site
Rennes Cedex 9, 35033
FranceActive - Recruiting
Research Site
Strasbourg, 67098
FranceActive - Recruiting
Research Site
Strasbourg Cedex, 67098
FranceSite Not Available
Research Site
Toulouse, 31059
FranceActive - Recruiting
Research Site
Bad Bramstedt, 24576
GermanySite Not Available
Research Site
Berlin, 10117
GermanySite Not Available
Research Site
Düsseldorf, 40225
GermanyActive - Recruiting
Research Site
Freiburg, 79106
GermanyActive - Recruiting
Research Site
Köln, 50937
GermanyActive - Recruiting
Research Site
Mainz, 55131
GermanyActive - Recruiting
Research Site
Minden, 32429
GermanyActive - Recruiting
Research Site
München, 80336
GermanyActive - Recruiting
Research Site
Münster, 48149
GermanyActive - Recruiting
Research Site
Tübingen, 72076
GermanyActive - Recruiting
Research Site
Budapest, 1138
HungaryActive - Recruiting
Research Site
Debrecen, 4032
HungaryActive - Recruiting
Research Site
Pécs, 7632
HungaryActive - Recruiting
Research Site
Szeged, 6725
HungaryActive - Recruiting
Research Site
Ahmedabad, 382421
IndiaActive - Recruiting
Research Site
Delhi, 110060
IndiaActive - Recruiting
Research Site
Gurugram, 122001
IndiaCompleted
Research Site
Hyderabad, 500082
IndiaActive - Recruiting
Research Site
Kolkata, 700020
IndiaActive - Recruiting
Research Site
Mumbai, 400053
IndiaActive - Recruiting
Research Site
Mysuru, 570004
IndiaActive - Recruiting
Research Site
New Delhi, 11029
IndiaActive - Recruiting
Research Site
Pune, 411001
IndiaActive - Recruiting
Research Site
Secunderabad, 500003
IndiaActive - Recruiting
Research Site
Visakhapatnam,
IndiaSite Not Available
Research Site
Afula, 18101
IsraelActive - Recruiting
Research Site
Hadera, 38100
IsraelSite Not Available
Research Site
Haifa, 31048
IsraelActive - Recruiting
Research Site
Jerusalem, 00000
IsraelActive - Recruiting
Research Site
Kfar-Saba, 4428164
IsraelActive - Recruiting
Research Site
Ramat Gan, 52621
IsraelActive - Recruiting
Research Site
Ancona, 60126
ItalyActive - Recruiting
Research Site
Brescia, 25123
ItalyActive - Recruiting
Research Site
Cona, 44124
ItalyActive - Recruiting
Research Site
Firenze, 50134
ItalySite Not Available
Research Site
Milano, 20132
ItalySite Not Available
Research Site
Monserrato, 09042
ItalyActive - Recruiting
Research Site
Napoli, 80131
ItalyActive - Recruiting
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Roma, 00168
ItalyActive - Recruiting
Research Site
Bunkyo-ku, 113-8603
JapanActive - Recruiting
Research Site
Fukuoka-shi, 812-8582
JapanActive - Recruiting
Research Site
Iruma-Gun, 350-0495
JapanActive - Recruiting
Research Site
Kanazawa-shi, 920-8641
JapanActive - Recruiting
Research Site
Maebashi-shi, 371-8511
JapanActive - Recruiting
Research Site
Nagasaki-shi, 852-8501
JapanActive - Recruiting
Research Site
Nagoya-shi, 457-0866
JapanActive - Recruiting
Research Site
Sapporo-shi, 060-8638
JapanActive - Recruiting
Research Site
Sendai-shi, 980-8574
JapanActive - Recruiting
Research Site
Shinjuku-ku, 160-8582
JapanActive - Recruiting
Research Site
Suita-shi, 565-0871
JapanActive - Recruiting
Research Site
Takatsuki-shi, 569-8686
JapanActive - Recruiting
Research Site
Toyoake-shi, 470-1192
JapanActive - Recruiting
Research Site
Yokohama-shi, 236-0004
JapanActive - Recruiting
Research Site
Busan, 49241
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 04401
Korea, Republic ofActive - Recruiting
Research Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Seremban, 70300
MalaysiaActive - Recruiting
Research Site
Cdmx, 06700
MexicoActive - Recruiting
Research Site
Chihuahua, 31000
MexicoActive - Recruiting
Research Site
Ciudad de Mexico, 06700
MexicoActive - Recruiting
Research Site
Guadalajara, 44158
MexicoActive - Recruiting
Research Site
Mexico City, 03310
MexicoSite Not Available
Research Site
México, 14000
MexicoSite Not Available
Research Site
San Luis Potosi, 78213
MexicoActive - Recruiting
Research Site
San Luis Potosí, 78250
MexicoActive - Recruiting
Research Site
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Research Site
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Research Site
Leiden, 2300 RC
NetherlandsSite Not Available
Research Site
Białystok, 15-276
PolandSite Not Available
Research Site
Bydgoszcz, 85-168
PolandActive - Recruiting
Research Site
Krakow, 31-637
PolandSite Not Available
Research Site
Kraków, 30-721
PolandActive - Recruiting
Research Site
Poznań, 60-218
PolandSite Not Available
Research Site
Sosnowiec, 41-200
PolandSite Not Available
Research Site
Warszawa, 00-874
PolandActive - Recruiting
Research Site
Łódź, 90-549
PolandActive - Recruiting
Research Site
Bucuresti, 011172
RomaniaActive - Recruiting
Research Site
Cluj Napoca, 400006
RomaniaActive - Recruiting
Research Site
Iasi, 700661
RomaniaActive - Recruiting
Research Site
Parktown, 2193
South AfricaActive - Recruiting
Research Site
Pretoria,
South AfricaActive - Recruiting
Research Site
Barcelona, 08041
SpainActive - Recruiting
Research Site
La Coruna, 15006
SpainSite Not Available
Research Site
La Coruña, 15006
SpainActive - Recruiting
Research Site
Madrid, 28041
SpainActive - Recruiting
Research Site
Malaga, 29009
SpainActive - Recruiting
Research Site
Valencia, 46026
SpainActive - Recruiting
Research Site
Vigo, 36214
SpainActive - Recruiting
Research Site
Ankara, 06100
TurkeyActive - Recruiting
Research Site
Antalya, 07059
TurkeyActive - Recruiting
Research Site
Başakşehir, 34480
TurkeySite Not Available
Research Site
Kazımkarabekir, 01230
TurkeySite Not Available
Research Site
Kocaeli, 41380
TurkeyActive - Recruiting
Research Site
Merkez, 23200
TurkeyActive - Recruiting
Research Site
Cannock, WS11 2XY
United KingdomActive - Recruiting
Research Site
Leeds, LS7 4SA
United KingdomActive - Recruiting
Research Site
London, NW3 2QG
United KingdomActive - Recruiting
Research Site
Manchester, M13 9WL
United KingdomActive - Recruiting
Research Site
Sheffield, S10 2JF
United KingdomActive - Recruiting
Research Site
Birmingham, Alabama 35205
United StatesActive - Recruiting
Research Site
Scottsdale, Arizona 85259
United StatesActive - Recruiting
Research Site
Chula Vista, California 91910
United StatesActive - Recruiting
Research Site
Inglewood, California 90301
United StatesActive - Recruiting
Research Site
Los Angeles, California 90095
United StatesActive - Recruiting
Research Site
Orange, California 92868
United StatesActive - Recruiting
Research Site
San Diego, California 92108
United StatesSite Not Available
Research Site
Aurora, Colorado 80045
United StatesActive - Recruiting
Research Site
New Haven, Connecticut 06519
United StatesActive - Recruiting
Research Site
North Haven, Connecticut 06473
United StatesSite Not Available
Research Site
Washington, District of Columbia 20007
United StatesActive - Recruiting
Research Site
Boca Raton, Florida 33486
United StatesActive - Recruiting
Research Site
Fort Lauderdale, Florida 33309
United StatesActive - Recruiting
Research Site
Gainesville, Florida 32603
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32224
United StatesActive - Recruiting
Research Site
Miami, Florida 33126
United StatesSite Not Available
Research Site
Tamarac, Florida 33321
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Chicago, Illinois 60611
United StatesActive - Recruiting
Research Site
Kansas City, Kansas 66160
United StatesActive - Recruiting
Research Site
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Research Site
Shreveport, Louisiana 71103
United StatesSite Not Available
Research Site
Baltimore, Maryland 21224
United StatesActive - Recruiting
Research Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Research Site
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Research Site
Babylon, New York 11702
United StatesActive - Recruiting
Research Site
Brooklyn, New York 11201
United StatesActive - Recruiting
Research Site
New York, New York 10032
United StatesActive - Recruiting
Research Site
Charlotte, North Carolina 28207
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site
Allen, Texas 75013
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Ha Noi, 100000
VietnamActive - Recruiting
Research Site
Hanoi City, 10000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 70000
VietnamActive - Recruiting
Research Site
Hochiminh, 70000
VietnamActive - Recruiting
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