Anifrolumab in Refractory Dermatomyositis and Antisynthetase Syndrome.
Ryan Bonaventure Soares, Jihad Ben Gabr, Mark Ash...
https://pubmed.ncbi.nlm.nih.gov/40297385Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID06455449
A Multicenter, Double-blind, Randomized Study of Weekly Subcutaneous Anifrolumab Added to Standard Care Compared With Placebo in Adults With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Led by AstraZeneca · Updated on 2026-05-28
240
Participants Needed
236
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), including polymyositis (PM) and dermatomyositis (DM). This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Body weight 40 kg or more
- Confirmed "probable" or "definite" diagnosis of polymyositis or dermatomyositis by 2017 classification criteria
- Moderate or severe disease activity based on core set measurements
- Currently on stable oral prednisone or other treatments for polymyositis or dermatomyositis
- No history of active tuberculosis or severe COVID-19
- Male and female participants must follow contraception guidelines
You will not qualify if you...
- Diagnosed with inclusion body myositis, immune-mediated necrotizing myositis, juvenile myositis diagnosed within 10 years, drug-induced myositis, cancer-associated myositis, amyopathic dermatomyositis, or non-inflammatory myopathies
- High risk of malignancy
- Rapidly progressive interstitial lung disease
- Severe muscle damage or permanent weakness due to other conditions like stroke
- History of severe herpes zoster infection
- History of cancer except treated basal cell carcinoma or cervical cancer in-situ
- Immunodeficiency, HIV, hepatitis B or active hepatitis C infection
- Recent unresolved cytomegalovirus or Epstein-Barr virus infection within 12 weeks
- Opportunistic infection requiring hospitalization or IV treatment within 3 years
- Recent non-opportunistic infection requiring hospitalization or anti-infective treatment
- Participation in another clinical study with investigational product
- Pregnant, breastfeeding, or intending to become pregnant or breastfeed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 52 weeks
Participants receive weekly subcutaneous injections of either anifrolumab or placebo, added to their standard care, to treat idiopathic inflammatory myopathies.
Weekly visits for up to 52 weeks
Treatment
Duration - 52 weeks
Following initial treatment, all participants receive open-label anifrolumab once weekly in addition to their standard care.
Weekly visits for up to 52 weeks
Trial Site Locations
Total: 236 locations
1
Research Site
Phoenix, Arizona, United States, 85032
Not Yet Recruiting
2
Research Site
Irvine, California, United States, 92617
Actively Recruiting
3
Research Site
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Research Site
Denver, Colorado, United States, 80230
Not Yet Recruiting
5
Research Site
New Haven, Connecticut, United States, 06519
Actively Recruiting
6
Research Site
Washington D.C., District of Columbia, United States, 20037
Withdrawn
7
Research Site
Boca Raton, Florida, United States, 33486
Actively Recruiting
8
Research Site
Boynton Beach, Florida, United States, 33472
Withdrawn
9
Research Site
Gainesville, Florida, United States, 32603
Withdrawn
10
Research Site
Margate, Florida, United States, 33063
Suspended
11
Research Site
Miami, Florida, United States, 33126
Withdrawn
12
Research Site
Miami, Florida, United States, 33133
Actively Recruiting
13
Research Site
Orlando, Florida, United States, 32819
Actively Recruiting
14
Research Site
Palm Beach Gardens, Florida, United States, 33410
Actively Recruiting
15
Research Site
Plant City, Florida, United States, 33563
Actively Recruiting
16
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Research Site
Willowbrook, Illinois, United States, 60527
Actively Recruiting
18
Research Site
Fairway, Kansas, United States, 66205
Actively Recruiting
19
Research Site
Baltimore, Maryland, United States, 21224
Actively Recruiting
20
Research Site
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
21
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
22
Research Site
Sterling Heights, Michigan, United States, 48313
Not Yet Recruiting
23
Research Site
Great Neck, New York, United States, 11021
Not Yet Recruiting
24
Research Site
Charlotte, North Carolina, United States, 28207
Withdrawn
25
Research Site
Charlotte, North Carolina, United States, 28211
Actively Recruiting
26
Research Site
Durham, North Carolina, United States, 27710
Actively Recruiting
27
Research Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
28
Research Site
Middleburg Heights, Ohio, United States, 44130
Withdrawn
29
Research Site
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
30
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
31
Research Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
32
Research Site
Summerville, South Carolina, United States, 29486
Actively Recruiting
33
Research Site
Allen, Texas, United States, 75013
Actively Recruiting
34
Research Site
Amarillo, Texas, United States, 79124
Not Yet Recruiting
35
Research Site
Austin, Texas, United States, 78759
Actively Recruiting
36
Research Site
Colleyville, Texas, United States, 76034
Actively Recruiting
37
Research Site
El Paso, Texas, United States, 79902
Actively Recruiting
38
Research Site
Galveston, Texas, United States, 77555
Withdrawn
39
Research Site
Harlingen, Texas, United States, 78550
Actively Recruiting
40
Research Site
Houston, Texas, United States, 77030
Withdrawn
41
Research Site
North Richland Hills, Texas, United States, 76180
Actively Recruiting
42
Research Site
Beckley, West Virginia, United States, 25801
Not Yet Recruiting
43
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
44
Research Site
Buenos Aires, Argentina, C1180AAX
Actively Recruiting
45
Research Site
CABA, Argentina, C1431FWO
Actively Recruiting
46
Research Site
Ciudad de Buenos Aires, Argentina, C1405BCH
Actively Recruiting
47
Research Site
Quilmes, Argentina, B1878GEG
Actively Recruiting
48
Research Site
San Miguel de Tucumán, Argentina, T4000AXL
Actively Recruiting
49
Research Site
Camperdown, Australia, 2050
Actively Recruiting
50
Research Site
Nedlands, Australia, 6009
Actively Recruiting
51
Research Site
New Lambton, Australia, 2310
Withdrawn
52
Research Site
Southport, Australia, 4222
Actively Recruiting
53
Research Site
Woodville South, Australia, 5011
Actively Recruiting
54
Research Site
Graz, Austria, 8036
Actively Recruiting
55
Research Site
Vienna, Austria, 1090
Actively Recruiting
56
Research Site
Ghent, Belgium, 9000
Actively Recruiting
57
Research Site
Leuven, Belgium, 3000
Actively Recruiting
58
Research Site
Merksem, Belgium, B-2170
Withdrawn
59
Research Site
Joinville, Brazil, 89202-190
Actively Recruiting
60
Research Site
Juiz de Fora, Brazil, 36010 570
Actively Recruiting
61
Research Site
Pelotas, Brazil, 96040-010
Withdrawn
62
Research Site
Porto Alegre, Brazil, 90620-110
Actively Recruiting
63
Research Site
Salvador, Brazil, 40150-150
Actively Recruiting
64
Research Site
Salvador, Brazil, 41253-190
Actively Recruiting
65
Research Site
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
66
Research Site
São Paulo, Brazil, 01233-907
Actively Recruiting
67
Research Site
São Paulo, Brazil, 5403-000
Not Yet Recruiting
68
Research Site
Haskovo, Bulgaria, 6304
Actively Recruiting
69
Research Site
Plovdiv, Bulgaria, 4001
Actively Recruiting
70
Research Site
Plovdiv, Bulgaria, 4002
Withdrawn
71
Research Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
72
Research Site
Rousse, Bulgaria, 7000
Not Yet Recruiting
73
Research Site
Sofia, Bulgaria, 1680
Actively Recruiting
74
Research Site
Stara Zagora, Bulgaria, 6003
Withdrawn
75
Research Site
Calgary, Alberta, Canada, T2N 4L7
Actively Recruiting
76
Research Site
Calgary, Alberta, Canada, T3M1M4
Withdrawn
77
Research Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
78
Research Site
Concepción, Chile, 4070022
Actively Recruiting
79
Research Site
Las Condes, Chile, 7560908
Actively Recruiting
80
Research Site
Osorno, Chile, 200025
Actively Recruiting
81
Research Site
Santiago, Chile, 7691236
Withdrawn
82
Research Site
Santiago, Chile, 8330034
Actively Recruiting
83
Research Site
Santiago, Chile, 8420383
Withdrawn
84
Research Site
Beijing, China, 100029
Actively Recruiting
85
Research Site
Beijing, China, 100044
Withdrawn
86
Research Site
Beijing, China, 100191
Actively Recruiting
87
Research Site
Beijing, China, CN-100730
Actively Recruiting
88
Research Site
Chongqing, China, 402260
Actively Recruiting
89
Research Site
Dongguan, China, 523009
Actively Recruiting
90
Research Site
Guangzhou, China, 510317
Actively Recruiting
91
Research Site
Guangzhou, China, 510630
Actively Recruiting
92
Research Site
Hangzhou, China, 310014
Actively Recruiting
93
Research Site
Hengyang, China, 421001
Actively Recruiting
94
Research Site
Jining, China, 272011
Actively Recruiting
95
Research Site
Nanjing, China, 210029
Actively Recruiting
96
Research Site
Shanghai, China, 200025
Actively Recruiting
97
Research Site
Shanghai, China, 200032
Actively Recruiting
98
Research Site
Shanghai, China, 200040
Actively Recruiting
99
Research Site
Shanghai, China
Actively Recruiting
100
Research Site
Shijiazhuang, China, 050001
Actively Recruiting
101
Research Site
Wenzhou, China, 325000
Actively Recruiting
102
Research Site
Zhengzhou, China, 450052
Actively Recruiting
103
Research Site
Prague, Czechia, 12850
Actively Recruiting
104
Research Site
Aarhus N, Denmark, 8200
Actively Recruiting
105
Research Site
Copenhagen, Denmark, 2100
Withdrawn
106
Research Site
Odense C, Denmark, 5000
Actively Recruiting
107
Research Site
Angers, France, 49033
Actively Recruiting
108
Research Site
Brest, France, 29609
Actively Recruiting
109
Research Site
Le Mans, France, 72037
Actively Recruiting
110
Research Site
Lille, France, 59037
Actively Recruiting
111
Research Site
Lyon, France, 69437
Actively Recruiting
112
Research Site
Paris, France, 75010
Actively Recruiting
113
Research Site
Paris, France, 75651
Actively Recruiting
114
Research Site
Reims, France, 51100
Actively Recruiting
115
Research Site
Rouen, France, 76000
Actively Recruiting
116
Research Site
Strasbourg, France, 67098
Actively Recruiting
117
Research Site
Toulouse, France, 31059
Actively Recruiting
118
Research Site
Bad Nauheim, Germany, 61231
Withdrawn
119
Research Site
Berlin, Germany, 10117
Actively Recruiting
120
Research Site
Bonn, Germany, 53127
Actively Recruiting
121
Research Site
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
122
Research Site
Herne, Germany, 44649
Not Yet Recruiting
123
Research Site
München, Germany, 80336
Actively Recruiting
124
Research Site
Tübingen, Germany, 72076
Actively Recruiting
125
Research Site
Budapest, Hungary, 1023
Not Yet Recruiting
126
Research Site
Debrecen, Hungary, 4032
Actively Recruiting
127
Research Site
Szeged, Hungary, 6725
Actively Recruiting
128
Research Site
Ahmedabad, India, 380006
Withdrawn
129
Research Site
Ahmedabad, India, 382421
Withdrawn
130
Research Site
Dehradun, India, 248016
Withdrawn
131
Research Site
Delhi, India, 110029
Not Yet Recruiting
132
Research Site
Gurugram, India, 122001
Withdrawn
133
Research Site
Hyderabad, India, 500082
Actively Recruiting
134
Research Site
Kolkata, India, 700020
Actively Recruiting
135
Research Site
Lucknow, India, 226030
Actively Recruiting
136
Research Site
Mumbai, India, 400 078
Withdrawn
137
Research Site
Mumbai, India, 400012
Withdrawn
138
Research Site
Mumbai, India, 400053
Actively Recruiting
139
Research Site
Mysuru, India, 570004
Actively Recruiting
140
Research Site
New Delhi, India, 110060
Withdrawn
141
Research Site
Puducherry, India, 605006
Withdrawn
142
Research Site
Secunderabad, India, 500003
Actively Recruiting
143
Research Site
Afula, Israel, 18101
Actively Recruiting
144
Research Site
Haifa, Israel, 31048
Actively Recruiting
145
Research Site
Haifa, Israel, 34362
Actively Recruiting
146
Research Site
Jerusalem, Israel, 91120
Actively Recruiting
147
Research Site
Kfar Saba, Israel, 4428164
Actively Recruiting
148
Research Site
Ramat Gan, Israel, 52621
Actively Recruiting
149
Research Site
Ancona, Italy, 60126
Actively Recruiting
150
Research Site
Bari, Italy, 70124
Actively Recruiting
151
Research Site
Catania, Italy, 95100
Actively Recruiting
152
Research Site
Milan, Italy, 20132
Actively Recruiting
153
Research Site
Milan, Italy, 20161
Withdrawn
154
Research Site
Padova, Italy, 35128
Actively Recruiting
155
Research Site
Palermo, Italy, 90127
Withdrawn
156
Research Site
Pavia, Italy, 27100
Actively Recruiting
157
Research Site
Pisa, Italy, 56126
Withdrawn
158
Research Site
Roma, Italy, 00128
Withdrawn
159
Research Site
Roma, Italy, 00161
Withdrawn
160
Research Site
Roma, Italy, 00189
Actively Recruiting
161
Research Site
Rozzano, Italy, 20089
Actively Recruiting
162
Research Site
Siena, Italy, 53100
Withdrawn
163
Research Site
Asahikawa-Shi, Japan, 070-8644
Actively Recruiting
164
Research Site
Bunkyō City, Japan, 113-8431
Actively Recruiting
165
Research Site
Bunkyō City, Japan, 113-8603
Actively Recruiting
166
Research Site
Chiba, Japan, 260-0877
Withdrawn
167
Research Site
Fukuoka, Japan, 810-8563
Actively Recruiting
168
Research Site
Hiroshima, Japan, 734-8551
Not Yet Recruiting
169
Research Site
Iruma-Gun, Japan, 350-0495
Actively Recruiting
170
Research Site
Kawachinagano-shi, Japan, 586-8521
Actively Recruiting
171
Research Site
Kawasaki-shi, Japan, 216-8511
Actively Recruiting
172
Research Site
Nagoya, Japan, 457-0866
Actively Recruiting
173
Research Site
Nagoya, Japan, 467-0001
Actively Recruiting
174
Research Site
Okayama, Japan, 700-8557
Actively Recruiting
175
Research Site
Omura-shi, Japan, 856-8562
Actively Recruiting
176
Research Site
Sendai, Japan, 980-8574
Actively Recruiting
177
Research Site
Shinjuku-ku, Japan, 160-8582
Actively Recruiting
178
Research Site
Tachikawa-shi, Japan, 190-0014
Actively Recruiting
179
Research Site
Yotsukaido-shi, Japan, 284-0003
Actively Recruiting
180
Research Site
Culiacán, Mexico, 80020
Actively Recruiting
181
Research Site
D.F, Mexico, 14000
Withdrawn
182
Research Site
Guadalajara, Mexico, 44600
Actively Recruiting
183
Research Site
Guadalajara, Mexico, 44650
Not Yet Recruiting
184
Research Site
Guadalajara, Mexico, 44690
Actively Recruiting
185
Research Site
Mexico City, Mexico, 03310
Actively Recruiting
186
Research Site
Mexico City, Mexico, 06700
Actively Recruiting
187
Research Site
México, Mexico, 06090
Withdrawn
188
Research Site
México, Mexico, 11850
Actively Recruiting
189
Research Site
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
190
Research Site
Bialystok, Poland, 15-276
Withdrawn
191
Research Site
Krakow, Poland, 30-002
Actively Recruiting
192
Research Site
Krakow, Poland, 30-105
Actively Recruiting
193
Research Site
Lodz, Poland, 90-549
Actively Recruiting
194
Research Site
Poznan, Poland, 60-218
Actively Recruiting
195
Research Site
Poznan, Poland, 61-545
Actively Recruiting
196
Research Site
Warsaw, Poland, 00-874
Actively Recruiting
197
Research Site
Warsaw, Poland, 02-637
Actively Recruiting
198
Research Site
Wroclaw, Poland, 50-556
Actively Recruiting
199
Research Site
Caguas, Puerto Rico, 00725
Actively Recruiting
200
Research Site
San Juan, Puerto Rico, 00918
Actively Recruiting
201
Research Site
Daejeon, South Korea, 35015
Actively Recruiting
202
Research Site
Seoul, South Korea, 02447
Actively Recruiting
203
Research Site
Seoul, South Korea, 04401
Actively Recruiting
204
Research Site
Seoul, South Korea, 06591
Actively Recruiting
205
Research Site
Seoul, South Korea, 133792
Actively Recruiting
206
Research Site
A Coruña, Spain, 15006
Active, Not Recruiting
207
Research Site
Barcelona, Spain, 08003
Actively Recruiting
208
Research Site
Barcelona, Spain, 08035
Actively Recruiting
209
Research Site
Barcelona, Spain, 08041
Actively Recruiting
210
Research Site
Córdoba, Spain, 14004
Actively Recruiting
211
Research Site
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
212
Research Site
Madrid, Spain, 28034
Actively Recruiting
213
Research Site
Madrid, Spain, 28041
Actively Recruiting
214
Research Site
Sabadell, Spain, 08208
Actively Recruiting
215
Research Site
Valladolid, Spain, 47012
Actively Recruiting
216
Research Site
Stockholm, Sweden, 171 76
Withdrawn
217
Research Site
Uppsala, Sweden, 751 85
Actively Recruiting
218
Research Site
Kaohsiung City, Taiwan, 81362
Actively Recruiting
219
Research Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
220
Research Site
New Taipei City, Taiwan, 220
Actively Recruiting
221
Research Site
Taichung, Taiwan, 40447
Terminated
222
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
223
Research Site
Taipei, Taiwan, 112
Withdrawn
224
Research Site
Taoyuan, Taiwan, 333
Withdrawn
225
Research Site
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
226
Research Site
London, United Kingdom, NW3 2QG
Actively Recruiting
227
Research Site
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
228
Research Site
Hanoi, Vietnam, 100000
Actively Recruiting
229
Research Site
Hanoi, Vietnam, 10000
Withdrawn
230
Research Site
Hà Nội, Vietnam, 100000
Actively Recruiting
231
Research Site
Hà Nội, Vietnam, 100000
Withdrawn
232
Research Site
Ho Chi Minh City, Vietnam, 700000
Withdrawn
233
Research Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
234
Research Site
Hochiminh City, Vietnam, 700000
Withdrawn
235
Research Site
Hồ Chí Minh, Vietnam, 700000
Actively Recruiting
236
Research Site
Huế, Vietnam, 530000
Actively Recruiting
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Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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