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NCT06624228CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
553 (actual)
First submitted
30 Sept 2024
Start date
21 Oct 2024
Primary completion date
6 Feb 2026
Lead sponsor
UCB Biopharma SRL
NCT number
NCT06624228
EU CT number
2024-511738-11-00
EudraCT number
2024-511738-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 553
  • From 21 Oct 2024 to the primary completion date, 6 Feb 2026
  • 133 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  • Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.
  • Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout period relative to the Baseline Visit.
  • Study participant is taking or has taken janus kinase (JAK) inhibitor.
  • Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.
  • Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.

Other illness

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
  • Participant has an active infection or a history of recent serious infections.
  • Participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
  • Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.
  • Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
  • Participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.

Other

  • Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study.
  • Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments.

Who the study is looking for

  • Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).
  • Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).
  • Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)
  • Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either:
  • experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or
  • been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pa0016 30002
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ClaytonAustraliaUnknown status
Pa0016 30034
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FootscrayAustraliaUnknown status
Pa0016 30033
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HeidelbergAustraliaUnknown status
Pa0016 30003
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MaroochydoreAustraliaUnknown status
Pa0016 30032
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ParramattaAustraliaUnknown status
Pa0016 30009
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Medical Center Medconsult Pleven OOD
Coordinator of this site? Confirm its status
PlevenBulgariaCompleted
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaCompleted
Medical center "Artmed" LTD
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PlovdivBulgariaCompleted
Medical Center Teodora EOOD
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RuseBulgariaCompleted
Dkc 1 Ruse EOOD
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RuseBulgariaCompleted
Medical Center Excelsior OOD
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SofiyaBulgariaCompleted
Dkc Fokus-5 Lzip OOD
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SofiyaBulgariaCompleted
Diagnostic Consulting Center XVII Sofia Ltd.
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SofiyaBulgariaCompleted
Medical Center Hera EOOD
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SofiyaBulgariaCompleted
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaCompleted
Pa0016 50041
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QuébecCanadaUnknown status
Pa0016 50044
Coordinator of this site? Confirm its status
Trois-RivièresCanadaUnknown status
Revmatologie s.r.o.
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Brno-SeverCzechiaCompleted
CCR Ostrava s.r.o.
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Moravska Ostrava A PrivozCzechiaCompleted
Vesalion s.r.o.
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Moravska Ostrava A PrivozCzechiaCompleted
Revmatologicky Ustav
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Prague 2CzechiaCompleted
MUDr. Zuzana Stejfova
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Praha 4CzechiaCompleted
MEDICAL PLUS s.r.o.
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Uherské HradištěCzechiaCompleted
PV Medical Services s.r.o.
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ZlínCzechiaCompleted
Kerckhoff-Klinik GmbH
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Bad NauheimGermanyCompleted
Rheumatologische Schwerpunktpraxis
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BerlinGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
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Frankfurt Am MainGermanyCompleted
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Studienambulanz Rheumazentrum Ratingen GbR
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RatingenGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitario Basurto
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BilbaoSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Pa0016 40833
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BarnetUnited KingdomUnknown status
Pa0016 40281
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LeedsUnited KingdomUnknown status
Pa0016 40827
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LutonUnited KingdomUnknown status
Pa0016 40237
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ManchesterUnited KingdomUnknown status
Pa0016 40306
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Newcastle upon TyneUnited KingdomUnknown status
Pa0016 40828
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ReadingUnited KingdomUnknown status
Pa0016 40108
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SalfordUnited KingdomUnknown status
Qualiclinic Kft.
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BudapestHungaryCompleted
Revita Kft.
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Budapest IIHungaryCompleted
Vasarhelyi Sarkanyfu Kft.
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HódmezővásárhelyHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Pa0016 20035
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Bunkyō CityJapanUnknown status
Pa0016 20045
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Kita-gunJapanUnknown status
Pa0016 20049
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KitakyushuJapanUnknown status
Pa0016 20069
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Meguro-kuJapanUnknown status
Pa0016 20336
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Mitaka-shiJapanUnknown status
Pa0016 20046
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OsakaJapanUnknown status
Pa0016 20041
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OsakaJapanUnknown status
Pa0016 20031
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SapporoJapanUnknown status
Pa0016 20043
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tabashi CityJapanUnknown status
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
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BialystokPolandCompleted
Clinicmed Daniluk Nowak Sp. k.
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BialystokPolandCompleted
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
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BialystokPolandCompleted
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandCompleted
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandCompleted
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandCompleted
Pratia S.A.
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CracowPolandCompleted
Malopolskie Badania Kliniczne Sp. z o.o.
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CracowPolandCompleted
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandCompleted
Provita Sp z o o
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KatowicePolandCompleted
Reumed Sp. z o.o.
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LublinPolandCompleted
NZOZ Lecznica MAK MED S C
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NadarzynPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandCompleted
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandCompleted
NOVAMED ROBERT KOTERAS
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OpolePolandCompleted
Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
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PoznanPolandCompleted
Medyczne Centrum Hetmańska Piotr Leszczyński
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PoznanPolandCompleted
Ai Centrum Medyczne Sp. z o.o. S.K.
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PoznanPolandCompleted
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
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PoznanPolandCompleted
RCMed Oddzial Sochaczew
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SochaczewPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandCompleted
Rheuma Medicus Sp z o o
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WarsawPolandCompleted
Etg Warszawa Sp. z o.o.
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WarsawPolandCompleted
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandCompleted
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandCompleted
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n.med. Jakub Trefler
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WarszawaPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
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WroclawPolandCompleted
WroMedica I Bielicka A Strzalkowska s c
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WroclawPolandCompleted
Pa0016 50653
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AlbuquerqueUnited StatesUnknown status
Pa0016 50666
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BrooklynUnited StatesUnknown status
Pa0016 50630
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ClearwaterUnited StatesUnknown status
Pa0016 50654
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CovinaUnited StatesUnknown status
Pa0016 50679
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Cutler BayUnited StatesUnknown status
Pa0016 50652
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DuncansvilleUnited StatesUnknown status
Pa0016 50689
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EaganUnited StatesUnknown status
Pa0016 50685
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Fort LauderdaleUnited StatesUnknown status
Pa0016 50673
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Fort WorthUnited StatesUnknown status
Pa0016 50662
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GilbertUnited StatesUnknown status
Pa0016 50062
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GlendaleUnited StatesUnknown status
Pa0016 50674
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GlendaleUnited StatesUnknown status
Pa0016 50686
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HagerstownUnited StatesUnknown status
Pa0016 50001
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JacksonUnited StatesUnknown status
Pa0016 50682
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Kansas CityUnited StatesUnknown status
Pa0016 50048
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KatyUnited StatesUnknown status
Pa0016 50665
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LansingUnited StatesUnknown status
Pa0016 50657
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LubbockUnited StatesUnknown status
Pa0016 50664
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MiddletownUnited StatesUnknown status
Pa0016 50059
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Ormond BeachUnited StatesUnknown status
Pa0016 50058
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PhoenixUnited StatesUnknown status
Pa0016 50324
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PlantationUnited StatesUnknown status
Pa0016 50551
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Saint Clair ShoresUnited StatesUnknown status
Pa0016 50663
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San DiegoUnited StatesUnknown status
Pa0016 50672
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Santa MonicaUnited StatesUnknown status
Pa0016 50651
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SkokieUnited StatesUnknown status
Pa0016 50061
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Spokane ValleyUnited StatesUnknown status
Pa0016 50016
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St LouisUnited StatesUnknown status
Pa0016 50131
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Sun CityUnited StatesUnknown status
Pa0016 50655
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TomballUnited StatesUnknown status
Pa0016 50680
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VandaliaUnited StatesUnknown status
Pa0016 50650
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WillowbrookUnited StatesUnknown status
Pa0016 50006
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WyomissingUnited StatesUnknown status
Pa0016 50678
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ZephyrhillsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.