Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Last updated: February 20, 2026
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Not Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Sonelokimab

Placebo

Clinical Study ID

NCT06641076
M1095-PSA-301
  • Ages > 18
  • All Genders

Study Summary

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be ≥18 years of age .

  2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 monthsbefore the Screening Visit.

  3. Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3and a 66 swollen joint count [SJC66] of ≥3).

  4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmedhistory of plaque PsO.

  5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinatedpeptide at the Screening Visit.

Exclusion

Exclusion Criteria:

  1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.

  2. Participants who have a diagnosis of chronic inflammatory conditions other than PsOor PsA.

  3. Participants with a diagnosis of inflammatory bowel disease.

  4. Participants who have experienced a period of ≥3 consecutive weeks of unexplaineddiarrhea in the 24 weeks before the Baseline Visit.

  5. Participants who have an established diagnosis of arthritis mutilans.

  6. Previous exposure to sonelokimab.

  7. Participants who have ever received any biologic immunomodulating agents for PsA orPsO, whether investigational or approved.

Study Design

Total Participants: 960
Treatment Group(s): 2
Primary Treatment: Sonelokimab
Phase: 3
Study Start date:
October 15, 2024
Estimated Completion Date:
February 04, 2027

Study Description

M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Connect with a study center

  • Clinical Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Clinical Site

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • Clinical Site

    Plovdiv, 4001
    Bulgaria

    Site Not Available

  • Clinical Site

    Plovdiv 728193, 4004
    Bulgaria

    Site Not Available

  • Clinical Site

    Rousse 727523, 7000
    Bulgaria

    Site Not Available

  • Clinical Site

    Ruse, 7000
    Bulgaria

    Site Not Available

  • Clinical Site

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Clinical Site

    Sofia 727011, 1606
    Bulgaria

    Site Not Available

  • Clinical Site

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Clinical Site

    Stara Zagora 726848, 6003
    Bulgaria

    Site Not Available

  • Clinical Site

    Calgary, T2N 4L7
    Canada

    Site Not Available

  • Clinical Site

    Calgary 5913490, T2N 4L7
    Canada

    Site Not Available

  • Clinical Site

    Trois-Rivières, G9A 3X2
    Canada

    Site Not Available

  • Clinical Site

    Trois-Rivières 6169141, G9A 3X2
    Canada

    Site Not Available

  • Clinical Site

    Waterloo, N2J 1C4
    Canada

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  • Clinical Site

    Waterloo 6176823, N2J 1C4
    Canada

    Site Not Available

  • Clinical Site

    Winnipeg, R3A IM3
    Canada

    Site Not Available

  • Clinical Site

    Winnipeg 6183235, R3A IM3
    Canada

    Site Not Available

  • Clinical Site

    Rijeka, 51 000
    Croatia

    Site Not Available

  • Clinical Site

    Rijeka 3191648, 51 000
    Croatia

    Site Not Available

  • Clinical Site

    Zagreb, 10000
    Croatia

    Site Not Available

  • Clinical Site

    Zagreb 3186886, 10000
    Croatia

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  • Clinical Site

    Brno, 63800
    Czechia

    Site Not Available

  • Clinical Site

    Brno 3078610, 63800
    Czechia

    Site Not Available

  • Clinical Site

    Břeclav, 690 02
    Czechia

    Site Not Available

  • Clinical Site

    Břeclav 3078773, 690 02
    Czechia

    Site Not Available

  • Clinical Site

    Ostrava, 70200
    Czechia

    Site Not Available

  • Clinical Site

    Ostrava 3068799, 70200
    Czechia

    Site Not Available

  • Clinical Site

    Prague 3067696, 140 00
    Czechia

    Site Not Available

  • Clinical Site

    Praha, 14800
    Czechia

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  • Clinical Site

    Studénka, 742 13
    Czechia

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  • Clinical Site

    Studénka 3064807, 742 13
    Czechia

    Site Not Available

  • Clinical Site

    Zlín, 760 01
    Czechia

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  • Clinical Site

    Zlín 3061370, 760 01
    Czechia

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  • Clinical Site

    Tallinn, 13419
    Estonia

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    Tallinn 588409, 10117
    Estonia

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    Tartu, 50708
    Estonia

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    Tartu 588335, 50708
    Estonia

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    Kuopio, 70100
    Finland

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    Kuopio 650224, 70100
    Finland

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    Cahors, 46000
    France

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    Cahors 3029213, 46000
    France

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    Caluire-et-Cuire, 69300
    France

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    Caluire-et-Cuire 3029096, 69300
    France

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    Montpellier, 34295
    France

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    Montpellier 2992166, 34295
    France

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    Narbona, 11100
    France

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    Narbonne 2990919, 11100
    France

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    Nice, 06001
    France

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    Nice 2990440, 06001
    France

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    Rouen, 76031
    France

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    Rouen 2982652, 76031
    France

    Site Not Available

  • Clinical Site

    Tours, 37170
    France

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  • Clinical Site

    Tours 2972191, 37170
    France

    Site Not Available

  • Clinical Site

    Échirolles 3020495, 38700
    France

    Site Not Available

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    Kutaisi, 4600
    Georgia

    Site Not Available

  • Clinical Site

    Kutaisi 613607, 4600
    Georgia

    Site Not Available

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    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Site

    Tbilisi 611717, 0159
    Georgia

    Site Not Available

  • Clinical Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Clinical Site

    Bad Bentheim 2953552, 48455
    Germany

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  • Clinical Site

    Berlin, 13125
    Germany

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  • Clinical Site

    Berlin 2950159, 12203
    Germany

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    Erlangen, 91054
    Germany

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    Erlangen 2929567, 91054
    Germany

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    Hamburg, 20095
    Germany

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  • Clinical Site

    Hamburg 2911298, 20095
    Germany

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  • Clinical Site

    Herne, 44649
    Germany

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  • Clinical Site

    Herne 2905891, 44649
    Germany

    Site Not Available

  • Clinical Site

    Muenchen, 80336
    Germany

    Site Not Available

  • Clinical Site

    Munich, 80639
    Germany

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  • Clinical Site

    Munich 2867714, 81667
    Germany

    Site Not Available

  • Clinical Site

    München 2867711, 80336
    Germany

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  • Clinical Site

    Athens 264371, Attica 6692632
    Greece

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    Heraklion, 71110
    Greece

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    Heraklion 261745, 71110
    Greece

    Site Not Available

  • Clinical SIte

    Budapest, 1023
    Hungary

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  • Clinical Site

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Clinical SIte

    Budapest 3054643, 1023
    Hungary

    Site Not Available

  • Clinical Site

    Budapest 3054643, 1036
    Hungary

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    Debrecen, H-4032
    Hungary

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    Debrecen 721472, H-4032
    Hungary

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    Gyula, 5700
    Hungary

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    Gyula 720334, 5700
    Hungary

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    Hódmezővásárhely, 6800
    Hungary

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    Hódmezővásárhely 719965, 6800
    Hungary

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    Kalocsa, 6300
    Hungary

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    Kalocsa 3050719, 6300
    Hungary

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    Kistarcsa, 2143
    Hungary

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    Kistarcsa 3050290, 2143
    Hungary

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    Nyíregyháza, 4400
    Hungary

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    Nyíregyháza 716935, 4400
    Hungary

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    Székesfehérvár, 8000
    Hungary

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    Székesfehérvár 3044774, 8000
    Hungary

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    Veszprém, 8200
    Hungary

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    Veszprém 3042929, 8200
    Hungary

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    Riga, LV-1001
    Latvia

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    Riga 456172, LV-1001
    Latvia

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    Ādaži, LV2164
    Latvia

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    Ādaži 461650, LV2164
    Latvia

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  • Clinical Site

    Kaunas, 51270
    Lithuania

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  • Clinical Site

    Kaunas 598316, 51270
    Lithuania

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  • Clinical Site

    Šiauliai, 76231
    Lithuania

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  • Clinical Site

    Šiauliai 594739, 76231
    Lithuania

    Site Not Available

  • Clinical Site

    Bialystok 776069, 15707
    Poland

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  • Clinical Site

    Białystok, 15707
    Poland

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  • Clinical Site

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Clinical Site

    Bydgoszcz 3102014, 85-168
    Poland

    Site Not Available

  • Clinical Site

    Bytom, 41-902
    Poland

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  • Clinical Site

    Bytom 3101950, 41-902
    Poland

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  • Clinical Site

    Częstochowa, 42-202
    Poland

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  • Clinical Site

    Częstochowa 3100946, 42-202
    Poland

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  • Clinical Site

    Dąbrówka, 62-069
    Poland

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  • Clinical Site

    Dąbrówka 773525, 62-069
    Poland

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  • Clinical Site

    Elblag 3099759, 82-300
    Poland

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  • Clinical Site

    Elbląg, 82-300
    Poland

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  • Clinical Site

    Gdynia, 81-384
    Poland

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  • Clinical Site

    Gdynia 3099424, 81-384
    Poland

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  • Clinical Site

    Krakow 3094802, 30-149
    Poland

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  • Clinical Site

    Kraków, 30-002
    Poland

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  • Clinical Site

    Lodz 3093133, 91-363
    Poland

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  • Clinical Site

    Lublin, 20-607
    Poland

    Site Not Available

  • Clinical Site

    Lublin 765876, 20-412
    Poland

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  • Clinical Site

    Nadarzyn, 05-830
    Poland

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  • Clinical Site

    Nadarzyn 764194, 05-830
    Poland

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  • Clinical Site

    Nowa Sól, 67-100
    Poland

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  • Clinical Site

    Nowa Sól 3090764, 67-100
    Poland

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  • Clinical Site

    Olsztyn, 10-117
    Poland

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  • Clinical Site

    Olsztyn 763166, 10-117
    Poland

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  • Clinical Site

    Poznan 3088171, 60-693
    Poland

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  • Clinical Site

    Poznań, 60-446
    Poland

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  • Clinical Site

    Siedlce, 08-110
    Poland

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  • Clinical Site

    Siedlce 759412, 08-110
    Poland

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  • Clinical Site

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Clinical Site

    Sochaczew 758682, 96-500
    Poland

    Site Not Available

  • Clinical Site

    Swidnica 3084093, 58100
    Poland

    Site Not Available

  • Clinical Site

    Torun 3083271, 87-100
    Poland

    Site Not Available

  • Clinical Site

    Toruń, 87-100
    Poland

    Site Not Available

  • Clinical Site

    Warsaw, 00-874
    Poland

    Site Not Available

  • Clinical Site

    Warsaw 756135, 00-874
    Poland

    Site Not Available

  • Clinical Site

    Warszawa, 01-691
    Poland

    Site Not Available

  • Clinical Site

    Wołomin, 05-200
    Poland

    Site Not Available

  • Clinical Site

    Wołomin 754800, 05-200
    Poland

    Site Not Available

  • Clinical Site

    Wroclaw 3081368, 51-685
    Poland

    Site Not Available

  • Clinical Site

    Wrocław, 51-685
    Poland

    Site Not Available

  • Clinical Site

    Łódź, 91-363
    Poland

    Site Not Available

  • Clinical Site

    Świdnica, 58100
    Poland

    Site Not Available

  • Clinical SIte

    Braga, 4700-000
    Portugal

    Site Not Available

  • Clinical Site

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Clinical SIte

    Braga 2742032, 4700-000
    Portugal

    Site Not Available

  • Clinical Site

    Braga 2742032, 4710-243
    Portugal

    Site Not Available

  • Clinical Site

    Lisbon, 1500-458
    Portugal

    Site Not Available

  • Clinical Site

    Lisbon 2267057, 1500-458
    Portugal

    Site Not Available

  • Clinical Site

    Bucharest, 020475
    Romania

    Site Not Available

  • Clinical Site

    Bucharest 683506, 011172
    Romania

    Site Not Available

  • Clinical Site

    Bucuresti, 012071
    Romania

    Site Not Available

  • Clinical Site

    Timişoara, 300650
    Romania

    Site Not Available

  • Clinical Site

    Timișoara 665087, 300650
    Romania

    Site Not Available

  • Clinical Site

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Clinical Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Clinical Site

    Novi Sad 3194360, 21000
    Serbia

    Site Not Available

  • Clinical Site

    Košice, 04011
    Slovakia

    Site Not Available

  • Clinical Site

    Košice 724443, 04011
    Slovakia

    Site Not Available

  • Clinical Site

    Martin, 036 01
    Slovakia

    Site Not Available

  • Clinical Site

    Martin 3058780, 036 01
    Slovakia

    Site Not Available

  • Clinical Site

    Poprad, 058 01
    Slovakia

    Site Not Available

  • Clinical Site

    Poprad 723846, 058 01
    Slovakia

    Site Not Available

  • Clinical Site

    Rimavská Sobota, 979 01
    Slovakia

    Site Not Available

  • Clinical Site

    Rimavská Sobota 723736, 979 01
    Slovakia

    Site Not Available

  • Clinical Site

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Clinical Site

    Bilbao 3128026, 48013
    Spain

    Site Not Available

  • Clinical Site

    Castelló, 12004
    Spain

    Site Not Available

  • Clinical Site

    Castelló 3125886, 12004
    Spain

    Site Not Available

  • Clinical Site

    Coruña, 15006
    Spain

    Site Not Available

  • Clinical Site

    Madrid, 28003
    Spain

    Site Not Available

  • Clinical Site

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Clinical Site

    Málaga, 29009
    Spain

    Site Not Available

  • Clinical Site

    Málaga 2514256, 29009
    Spain

    Site Not Available

  • Clinical Site

    Sabadell, 08208
    Spain

    Site Not Available

  • Clinical Site

    Sabadell 3111199, 08208
    Spain

    Site Not Available

  • Clinical Site

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Clinical Site

    Santiago de Compostela 3109642, 15706
    Spain

    Site Not Available

  • Clinical Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Clinical Site

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Clinical Site

    Valencia, 46007
    Spain

    Site Not Available

  • Clinical Site

    Valencia 2509954, 46007
    Spain

    Site Not Available

  • Clinical Site

    Avondale, Arizona 85392
    United States

    Site Not Available

  • Clinical Site

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Clinical Site

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Clinical Site

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Clinical Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Clinical Site

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Clinical Site

    Tucson, Arizona 85748
    United States

    Site Not Available

  • Clinical Site

    Avondale 5552301, Arizona 5551752 85392
    United States

    Site Not Available

  • Clinical Site

    Chandler 5289282, Arizona 5551752 85225
    United States

    Site Not Available

  • Clinical Site

    Flagstaff 5294810, Arizona 5551752 86001
    United States

    Site Not Available

  • Clinical Site

    Mesa 5304391, Arizona 5551752 85210
    United States

    Site Not Available

  • Clinical Site

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Site Not Available

  • Clinical Site

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Clinical Site

    Tucson 5318313, Arizona 5551752 85748
    United States

    Site Not Available

  • Clinical Site

    San Diego, California 92108
    United States

    Site Not Available

  • Clinical Site

    Upland, California 91786
    United States

    Site Not Available

  • Clinical Site

    San Diego 5391811, California 5332921 92108
    United States

    Site Not Available

  • Clinical Site

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Clinical Site

    Avon Park, Florida 33825
    United States

    Site Not Available

  • Clinical Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Clinical Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Clinical Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Clinical Site

    Avon Park 4146440, Florida 4155751 33825
    United States

    Site Not Available

  • Clinical Site

    Clearwater 4151316, Florida 4155751 33765
    United States

    Site Not Available

  • Clinical Site

    Hialeah 4158476, Florida 4155751 33016
    United States

    Site Not Available

  • Clinical Site

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Clinical Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Clinical Site

    Springfield 4250542, Illinois 4896861 62702
    United States

    Site Not Available

  • Clinical Site

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Clinical Site

    Lake Charles 4330236, Louisiana 4331987 70605
    United States

    Site Not Available

  • Clinical Site

    Baltimore 4347778, Maryland 4361885 21224-6821
    United States

    Site Not Available

  • Clinical Site

    Grand Blanc, Michigan 48439-2451
    United States

    Site Not Available

  • Clinical Site

    Grand Blanc 4994320, Michigan 5001836 48439-2451
    United States

    Site Not Available

  • Clinical Site

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Clinical Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Clinical Site

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Clinical Site

    Leland 4475622, North Carolina 4482348 28451
    United States

    Site Not Available

  • Clinical Site

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Site Not Available

  • Clinical Site

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Site Not Available

  • Clinical Site

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Clinical Site

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Site Not Available

  • Clinical Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Clinical Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Clinical Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Site

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Clinical Site

    Allen, Texas 75013
    United States

    Site Not Available

  • Clinical Site

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Clinical Site

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Clinical Site

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Clinical Site

    Plano, Texas 75024
    United States

    Site Not Available

  • Clinical Site

    Allen 4670300, Texas 4736286 75013
    United States

    Site Not Available

  • Clinical Site

    Colleyville 4682478, Texas 4736286 76034
    United States

    Site Not Available

  • Clinical Site

    Lubbock 5525577, Texas 4736286 79424
    United States

    Site Not Available

  • Clinical Site

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • Clinical Site

    Beckley, West Virginia 25801
    United States

    Site Not Available

  • Clinical Site

    Beckley 4798308, West Virginia 4826850 25801
    United States

    Site Not Available

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