Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Comparing Subcutaneous Sonelokimab to Placebo and Risankizumab in Adults with Active Psoriatic Arthritis and Previous Inadequate Response to Tumor Necrosis Factor-alpha Inhibitors
Led by MoonLake Immunotherapeutics AG · Updated on 2026-05-18
600
Participants Needed
136
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy and safety of sonelokimab compared with placebo in adults with active psoriatic arthritis who have previously shown inadequate response or intolerance to anti-tumor necrosis factor (TNF) alpha therapy. This Phase 3, randomized, double-blind, placebo-controlled study also includes risankizumab as an active reference to further assess treatment options for this condition. Participants are assigned to one of four groups: two different doses of sonelokimab given by subcutaneous injection as an induction regimen of four doses followed by maintenance dosing every four weeks starting at Week 8, a placebo group receiving subcutaneous injections, or a group receiving risankizumab by subcutaneous injection. The study compares the effects of these treatments over time. Throughout the study, participants will undergo regular assessments for improvement in psoriatic arthritis symptoms using the American College of Rheumatology criteria (ACR50 and ACR20) and other measures like Minimal Disease Activity, the Health Assessment Questionnaire Disability Index, Psoriasis Area and Severity Index, and quality of life surveys. Safety and response rates will be closely monitored, with primary outcome measurement at Week 16. The study is expected to continue until January 2027.
CONDITIONS
Brief Title
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Confirmed diagnosis of psoriatic arthritis according to 2006 CASPAR criteria with symptoms for at least 6 months before screening.
- Active disease with at least 3 tender joints and 3 swollen joints.
- Current active plaque psoriasis or a dermatologist-confirmed history of plaque psoriasis.
- Negative test results for rheumatoid factor and anti-cyclic citrullinated peptide at screening.
- Previous treatment with one or more TNF-alpha inhibitors for psoriatic arthritis or psoriasis with inadequate response for at least 3 months or stopped due to safety or tolerability issues after at least one administration.
You will not qualify if you...
- Known hypersensitivity to sonelokimab or any of its ingredients.
- Known hypersensitivity or contraindication to risankizumab or any of its ingredients or container components.
- Diagnosis of chronic inflammatory conditions other than psoriasis or psoriatic arthritis.
- Diagnosis of inflammatory bowel disease.
- Experienced 3 or more consecutive weeks of unexplained diarrhea within 24 weeks before baseline.
- Established diagnosis of arthritis mutilans.
- Previous exposure to sonelokimab.
- Prior use of biologic immunomodulating agents for psoriatic arthritis or psoriasis other than TNF-alpha inhibitors, whether investigational or approved.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive subcutaneous injections of sonelokimab, placebo, or risankizumab as assigned. Sonelokimab is given with an induction regimen of 4 doses followed by maintenance dosing every 4 weeks starting at Week 8.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 136 locations
1
Clinical Site
Avondale, Arizona, United States, 85392
Actively Recruiting
2
Clinical Site
Chandler, Arizona, United States, 85225
Completed
3
Clinical Site
Flagstaff, Arizona, United States, 86001
Completed
4
Clinical Site
Mesa, Arizona, United States, 85210
Actively Recruiting
5
Clinical Site
Phoenix, Arizona, United States, 85032
Actively Recruiting
6
Clinical Site
Scottsdale, Arizona, United States, 85260
Actively Recruiting
7
Clinical Site
Tucson, Arizona, United States, 85748
Actively Recruiting
8
Clinical Site
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
9
Clinical Site
La Jolla, California, United States, 92037
Actively Recruiting
10
Clinical Site
Pomona, California, United States, 91767
Actively Recruiting
11
Clinical Site
San Diego, California, United States, 92108
Actively Recruiting
12
Clinical Site
Santa Monica, California, United States, 90404
Actively Recruiting
13
Clinical Site
Thousand Oaks, California, United States, 91360
Actively Recruiting
14
Clinical Site
Upland, California, United States, 91786
Actively Recruiting
15
Clinical Site
Avon Park, Florida, United States, 33825
Actively Recruiting
16
Clinical Site
Clearwater, Florida, United States, 33765
Actively Recruiting
17
Clinical Site
Hialeah, Florida, United States, 33016
Actively Recruiting
18
Clinical Site
Miami Gardens, Florida, United States, 33014
Actively Recruiting
19
Clinical Site
Tampa, Florida, United States, 33607
Actively Recruiting
20
Clinical Site
Zephyrhills, Florida, United States, 33542
Actively Recruiting
21
Clinical Site
Gainesville, Georgia, United States, 30501
Actively Recruiting
22
Clinical Site
Springfield, Illinois, United States, 62702
Actively Recruiting
23
Clinical Site
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
24
Clinical Site
Baltimore, Maryland, United States, 21224-6821
Actively Recruiting
25
Clinical Site
Grand Blanc, Michigan, United States, 48439-2451
Actively Recruiting
26
Clinical Site
Brooklyn, New York, United States, 11201
Actively Recruiting
27
Clinical Site
Rochester, New York, United States, 14642
Actively Recruiting
28
Clinical Site
Charlotte, North Carolina, United States, 28262
Actively Recruiting
29
Clinical Site
Leland, North Carolina, United States, 28451
Actively Recruiting
30
Clinical Site
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
31
Clinical Site
Portland, Oregon, United States, 97239
Actively Recruiting
32
Clinical Site
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
33
Clinical Site
Jackson, Tennessee, United States, 38305
Actively Recruiting
34
Clinical Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
35
Clinical Site
Murfreesboro, Tennessee, United States, 37128
Completed
36
Clinical Site
Allen, Texas, United States, 75013
Completed
37
Clinical Site
Austin, Texas, United States, 78745
Actively Recruiting
38
Clinical Site
Baytown, Texas, United States, 77521
Actively Recruiting
39
Clinical Site
Colleyville, Texas, United States, 76034
Actively Recruiting
40
Clinical Site
Houston, Texas, United States, 77089
Completed
41
Clinical Site
Lubbock, Texas, United States, 79424
Actively Recruiting
42
Clinical Site
Plano, Texas, United States, 75024
Actively Recruiting
43
Clinical Site
Seattle, Washington, United States, 98122
Actively Recruiting
44
Clinical Site
Beckley, West Virginia, United States, 25801
Actively Recruiting
45
Clinical Site
Pazardzhik, Bulgaria, 4400
Actively Recruiting
46
Clinical Site
Pleven, Bulgaria, 5800
Actively Recruiting
47
Clinical Site
Plovdiv, Bulgaria, 4000
Actively Recruiting
48
Clinical Site
Plovdiv, Bulgaria, 4001
Actively Recruiting
49
Clinical Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
50
Clinical Site
Plovdiv, Bulgaria, 4003
Actively Recruiting
51
Clinical Site
Plovdiv, Bulgaria, 4004
Actively Recruiting
52
Clinical Site
Rousse, Bulgaria, 7000
Actively Recruiting
53
Clinical Site
Sofia, Bulgaria, 1606
Actively Recruiting
54
Clinical Site
Sofia, Bulgaria, 1784
Completed
55
Clinical Site
Stara Zagora, Bulgaria, 6003
Actively Recruiting
56
Clinical Site
Toronto, Ontario, Canada, M5S1B2
Actively Recruiting
57
Clinical Site
Calgary, Canada, T2N 4L7
Actively Recruiting
58
Clinical Site
Trois-Rivières, Canada, G9A 3X2
Actively Recruiting
59
Clinical Site
Waterloo, Canada, N2J 1C4
Actively Recruiting
60
Clinical Site
Winnipeg, Canada, R3A IM3
Actively Recruiting
61
Clinical Site
Brno, Czechia, 63800
Actively Recruiting
62
Clinical Site
Ostrava, Czechia, 70200
Actively Recruiting
63
Clinical Site
Studénka, Czechia, 742 13
Actively Recruiting
64
Clinical Site
Zlín, Czechia, 760 01
Actively Recruiting
65
Clinical Site
Caluire-et-Cuire, France, 69300
Actively Recruiting
66
Clinical Site
Montpellier, France, 34295
Actively Recruiting
67
Clinical Site
Narbonne, France, 11100
Completed
68
Clinical Site
Nice, France, 06001
Actively Recruiting
69
Clinical Site
Rouen, France, 76031
Actively Recruiting
70
Clinical Site
Tours, France, 37170
Actively Recruiting
71
Clinical Site
Tbilisi, Georgia, 0102
Actively Recruiting
72
Clinical Site
Tbilisi, Georgia, 0112
Actively Recruiting
73
Clinical Site
Tbilisi, Georgia, 0141
Actively Recruiting
74
Clinical Site
Tbilisi, Georgia, 0159
Actively Recruiting
75
Clinical Site
Tbilisi, Georgia, 0179
Actively Recruiting
76
Clinical Site
Tbilisi, Georgia, 0180
Actively Recruiting
77
Clinical Site
Berlin, Germany, 12161
Actively Recruiting
78
Clinical Site
Berlin, Germany, 12203
Actively Recruiting
79
Clinical Site
Berlin, Germany, 13125
Actively Recruiting
80
Clinical Site
Dresden, Germany, 01067
Actively Recruiting
81
Clinical Site
Erlangen, Germany, 91054
Actively Recruiting
82
Clinical Site
Hamburg, Germany, 20095
Actively Recruiting
83
Clinical Site
Herne, Germany, 44649
Actively Recruiting
84
Clinical Site
Munich, Germany, 80639
Actively Recruiting
85
Clinical Site
Munich, Germany, 81667
Actively Recruiting
86
Clinical Site
München, Germany, 80336
Actively Recruiting
87
Clinical Site
Budapest, Hungary, 1027
Actively Recruiting
88
Clinical Site
Budapest, Hungary, 1036
Actively Recruiting
89
Clinical Site
Budapest, Hungary, 1036
Completed
90
Clinical Site
Debrecen, Hungary, H-4032
Actively Recruiting
91
Clinical SIte
Gyula, Hungary, 5700
Actively Recruiting
92
Clinical Site
Hódmezővásárhely, Hungary, 6800
Actively Recruiting
93
Clinical Site
Nyíregyháza, Hungary, 4400
Actively Recruiting
94
Clinical Site
Székesfehérvár, Hungary, 8000
Actively Recruiting
95
Clinical Site
Szolnok, Hungary, 5000
Actively Recruiting
96
Clinical Site
Veszprém, Hungary, 8200
Actively Recruiting
97
Clinical Site
Bialystok, Poland, 15707
Actively Recruiting
98
Clinical Site
Bydgoszcz, Poland, 85-065
Actively Recruiting
99
Clinical Site
Częstochowa, Poland, 42-202
Completed
100
Clinical Site
Elblag, Poland, 82-300
Actively Recruiting
101
Clinical Site
Gdynia, Poland, 81-384
Actively Recruiting
102
Clinical Site
Krakow, Poland, 30-002
Actively Recruiting
103
Clinical Site
Krakow, Poland, 30-149
Actively Recruiting
104
Clinical Site
Krakow, Poland, 31-501
Actively Recruiting
105
Clinical Site
Lodz, Poland, 91-363
Actively Recruiting
106
Clinical Site
Nadarzyn, Poland, 05-830
Actively Recruiting
107
Clinical Site
Poznan, Poland, 60-324
Actively Recruiting
108
Clinical Site
Poznan, Poland, 60-446
Actively Recruiting
109
Clinical Site
Poznan, Poland, 60-693
Actively Recruiting
110
Clinical Site
Poznan, Poland, 61-397
Actively Recruiting
111
Clinical Site
Sochaczew, Poland, 96-500
Actively Recruiting
112
Clinical Site
Swidnica, Poland, 58100
Actively Recruiting
113
Clinical Site
Warsaw, Poland, 00-874
Actively Recruiting
114
Clinical Site
Warsaw, Poland, 02-118
Actively Recruiting
115
Clinical Site
Warsaw, Poland, 02-665
Actively Recruiting
116
Clinical Site
Warsaw, Poland, 02-677
Actively Recruiting
117
Clinical Site
Warsaw, Poland, 03-291
Actively Recruiting
118
Clinical Site
Warsaw, Poland, 04-305
Actively Recruiting
119
Clinical Site
Wołomin, Poland, 05-200
Actively Recruiting
120
Clinical Site
Wroclaw, Poland, 51-685
Actively Recruiting
121
Clinical Site
Wroclaw, Poland, 53-673
Actively Recruiting
122
Clinical Site
A Coruña, Spain, 15006
Actively Recruiting
123
Clinical Site
Bilbao, Spain, 48013
Actively Recruiting
124
Clinical Site
Castellon, Spain, 12004
Actively Recruiting
125
Clinical Site
Madrid, Spain, 28003
Actively Recruiting
126
Clinical Site
Málaga, Spain, 29009
Actively Recruiting
127
Clinical SIte
Sabadell, Spain, 08208
Actively Recruiting
128
Clinical Site
Santiago de Compostela, Spain, 15702
Actively Recruiting
129
Clinical Site
Santiago de Compostela, Spain, 15706
Actively Recruiting
130
Clinical Site
Seville, Spain, 41009
Actively Recruiting
131
Clinical Site
Seville, Spain, 41010
Actively Recruiting
132
Clinical Site
Seville, Spain, 41013
Actively Recruiting
133
Clinical Site
Valencia, Spain, 46010
Actively Recruiting
134
Clinical Site
Westcliff-on-Sea, Essex, United Kingdom, SS0
Actively Recruiting
135
Clinical Site
Barnet, United Kingdom, EN5 3DJ
Actively Recruiting
136
Clinical Site
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
Research Team
M
Moonlake Clinical Trial Helpdesk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here