An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice (PROFUNDUS)

February 27, 2025 updated by: AbbVie

Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5016
        • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
    • Ciudad Autonoma De Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1115
        • Gedyt /ID# 249611
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires /ID# 249605
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital /ID# 248354
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital /ID# 248351
    • Queensland
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research institute /ID# 248352
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health /ID# 249133
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital /ID# 248353
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 259183
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and Internal Medicine Research Institution /ID# 251463
      • Edmonton, Alberta, Canada, T6L 6K3
        • Dr. J Siffledeen Profess Pract /ID# 256903
      • Lethbridge, Alberta, Canada, T1J 4G9
        • Six08 Gastroenterology /ID# 259452
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 6J6
        • Dr. Sundeep Singh, Inc /ID# 251471
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital /ID# 257337
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Barrie GI Associates /ID# 264978
      • Hamilton, Ontario, Canada, L8S 4K1
        • Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center- University Hospital /ID# 258472
      • Mississauga, Ontario, Canada, L5M 2S4
        • West GTA Endoscopy /ID# 263221
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation /ID# 256826
      • North York, Ontario, Canada, M6A 3B4
        • Toronto Immune and Digestive Health Institute Inc /ID# 256827
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates /ID# 258914
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital / McGill University Health Centre /ID# 258470
      • Québec, Quebec, Canada, G1V 4T3
        • Diex Recherche Québec /ID# 262796
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 259810
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 261535
      • Praha, Czechia, 140 59
        • Fakultni Thomayerova nemocnice /ID# 261626
    • Jihomoravsky Kraj
      • Brno, Jihomoravsky Kraj, Czechia, 602 00
        • SurGal Clinic /ID# 259809
    • Praha 9
      • Prague, Praha 9, Czechia, 190 00
        • Iscare Klinické Centrum /ID# 259811
  • France
      • Bethune CEDEX, France, 62408
        • Ch Bethune - Beuvry /Id# 252233
      • Cagnes Sur Mer, France, 06800
        • Pole Sante Saint-Jean /ID# 252235
      • Epagny Metz Tessy, France, 74370
        • CH Annecy Genevois - Site Annecy /ID# 253010
      • Montfermeil, France, 93370
        • GHI Le Raincy - Montfermeil /ID# 252733
      • Nantes, France, 44300
        • Clinique Jules Verne /ID# 251969
      • Orléans, France, 45067
        • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252125
      • Paris, France, 75014
        • Institut Mutualiste Montsouris /ID# 251849
      • Rennes, France, 35033
        • CHRU Pontchaillou /ID# 252015
      • Strasbourg, France, 67000
        • Centres des maladies de l'appareil digestif /ID# 252283
      • Toulouse CEDEX 3, France, 31076
        • Clinique Pasteur /ID# 251893
      • Vantoux, France, 57070
        • Hôpital Schuman /ID# 252995
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Chu de Nice-Hopital L'Archet Ii /Id# 251938
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13015
        • APHM - Hopital Nord /ID# 252049
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU de Besancon - Jean Minjoz /ID# 252966
    • Gard
      • Nimes CEDEX 9, Gard, France, 30029
        • CHU NIMES - Hopital Caremeau /ID# 254790
    • Grand-Est
      • Colmar CEDEX, Grand-Est, France, 68024
        • Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 252496
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • CHU Toulouse - Hopital Rangueil /ID# 251879
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 252041
    • Ile-de-France
      • Neuilly Sur Seine, Ile-de-France, France, 92200
        • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252565
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 251937
    • Loire
      • St-Priest-en-Jarez, Loire, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 252265
    • Loire-Atlantique
      • St Herblain CEDEX, Loire-Atlantique, France, 44819
        • Clinique Santé Atlantique /ID# 252581
    • Marne
      • Reims CEDEX, Marne, France, 51092
        • CHU Reims - Hôpital Robert Debre /ID# 252017
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 251971
    • Paris
      • Creteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 251972
      • Le Kremlin Bicetre, Paris, France, 94270
        • AP-HP - Hopital Bicetre /ID# 252329
    • Provence-Alpes-Cote-d Azur
      • Avignon, Provence-Alpes-Cote-d Azur, France, 84000
        • Centre Hospitalier D'Avignon /ID# 252657
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Centre Hospitalier de la Cote Basque /ID# 252358
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • HCL - Hopital Lyon Sud /ID# 252093
    • Somme
      • Amiens, Somme, France, 80090
        • Clinique de l'Europe /ID# 251851
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 252103
  • Germany
      • Alzey, Germany, 55232
        • Dr. Bernd Adami /ID# 248123
      • Andernach, Germany, 56626
        • Dr. Heil /ID# 248273
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 248979
      • Berlin, Germany, 10318
        • Praxis Dr. Michael Mross /ID# 248272
      • Berlin-Zehlendorf, Germany, 14163
        • Krankenhaus Waldfriede /ID# 248307
      • Eschweiler, Germany, 52249
        • Praxis Dr. Lukas Buendgens & Dr. Burkhard Buendgens /ID# 254873
      • Freiburg im Breisgau, Germany, 79102
        • Dres. Bauer/Doerflinger /ID# 252107
      • Halle (Saale), Germany, 06108
        • Dres. Behrens/Fechner/Streudel /ID# 250872
      • Hamburg, Germany, 22767
        • Miamedes Hausarztpraxis Altona /ID# 260064
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 257454
      • Herne, Germany, 44623
        • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 250262
      • Leipzig, Germany, 04107
        • Dres. Breitschwerdt/Glas/Gurtler /ID# 251192
      • Muenster, Germany, 48159
        • Gastro Campus Research GbR /ID# 249867
      • Münster, Germany, 48149
        • Bettenworth & Partner /ID# 248977
      • Nienburg (Weser), Germany, 31582
        • Gastro.Praxis am Meerbachbogen /ID# 251856
      • Nuernberg, Germany, 90449
        • Praxis Dres Brendel /ID# 250559
      • Remscheid, Germany, 42859
        • Schwerpunktpraxis Gastroenterologie Dr. Ingomar Scheller /ID# 250581
      • Tostedt, Germany, 21255
        • Praxis Dr. Kempelmann /ID# 257748
    • Bayern
      • Dachau, Bayern, Germany, 85221
        • Medizinisches Versorgunszentrum Dachau /ID# 257231
    • Hessen
      • Darmstadt, Hessen, Germany, 64293
        • Praxis Dres. Hurst/Simonis /ID# 255159
      • Frankfurt, Hessen, Germany, 60318
        • Interdisziplinaeres Crohn Colitis Zentrum /ID# 252224
      • Frankfurt am Main, Hessen, Germany, 60431
        • Markus Krankenhaus /ID# 260648
      • Kassel, Hessen, Germany, 34117
        • Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 252076
    • Nordrhein-Westfalen
      • Remscheid, Nordrhein-Westfalen, Germany, 42859
        • Magen-Darm-Zentrum-Remscheid /ID# 250339
    • Rheinland-Pfalz
      • Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67067
        • Duplicate_St. Marien- und Annastiftskrankenhaus /ID# 255158
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 251824
    • Sachsen
      • Leipzig, Sachsen, Germany, 04105
        • Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 250873
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06108
        • Private Practice - Dr. Thomas Zeisler /ID# 250126
    • Schleswig-Holstein
      • Büdelsdorf, Schleswig-Holstein, Germany, 24782
        • Praxis S. Tetzlaff /ID# 248263
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Thurman/Bethge /ID# 248305
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 251273
      • Lübeck, Schleswig-Holstein, Germany, 23560
        • Praxis fuer Gastroenterologie /ID# 250749
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259870
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Hippokrateio /ID# 260785
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
      • Athens, Attiki, Greece, 11528
        • Alexandra General Hospital /ID# 260786
      • Nikaia, Attiki, Greece, 18454
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 250794
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • University General Hospital of Alexandroupoli /ID# 270159
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 259869
  • Ireland
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 253427
    • Dublin
      • Abbotstown, Dublin, Ireland, D15 X40D
        • Connolly Hospital Blanchardstown /ID# 252190
      • Elm Park, Dublin, Ireland, D04 T6F4
        • St Vincent's University Hospital /ID# 251855
  • Israel
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 249474
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Rambam Health Care Campus /ID# 249884
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8410101
        • Soroka University Medical Center /ID# 249885
    • HaMerkaz
      • Beer Ya'akov, HaMerkaz, Israel, 70300
        • Shamir Medical Center /ID# 256885
    • Tel-Aviv
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 250562
  • Italy
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260812
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261052
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana /ID# 261126
    • Bari
      • Castellana Grotte, Bari, Italy, 70013
        • Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • IRCCS Istituto Clinico Humanitas /ID# 260801
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 261058
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 260802
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260811
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 260946
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 261116
  • Kuwait
      • Hawalli, Kuwait, 46300
        • Mubarak Hospital /ID# 252026
  • Portugal
      • Faro, Portugal, 8000-386
        • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 260517
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 260524
      • Lisboa, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria, EPE /ID# 258759
      • Loures, Portugal, 2674-514
        • Unidade Local de Saude de Loures-Odivelas, EPE /ID# 272785
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 260038
      • Viseu, Portugal, 3504-509
        • Centro Hosp de Tondela-Viseu /ID# 258760
    • Regiao Autonoma Da Madeira
      • Funchal, Regiao Autonoma Da Madeira, Portugal, 9000-177
        • Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
    • Setubal
      • Almada, Setubal, Portugal, 2805-267
        • Hospital Garcia de Orta /ID# 264420
  • Qatar
    • Ar Rayyan
      • Zone 51, Ar Rayyan, Qatar
        • Hamad Medical Corporation /ID# 253823
  • Russian Federation
      • Voronezh, Russian Federation, 394066
        • Voronezh Regional Clinical Hospital #1 /ID# 249932
  • Spain
      • Almería, Spain, 04009
        • Hospital Universitario Torrecárdenas /ID# 264202
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jiménez /ID# 267702
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca /ID# 264207
    • Asturias
      • Gijón, Asturias, Spain, 33394
        • Hospital de Cabueñes /ID# 263930
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge /ID# 263932
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli /ID# 263931
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263929
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias /ID# 264214
    • Sevilla
      • Seville, Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 263924
      • Seville, Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 263926
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo /ID# 263925
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 113818
        • Burjeel Day Surgery Center /ID# 252030
      • Abu Dhabi, United Arab Emirates
        • Cleveland Clinic Abu Dhabi /ID# 252038
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Ulster Hospital - South Eastern Health & Social Care Trust /ID# 255265
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust /ID# 253989
      • London, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 252735
      • Tooting, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust /ID# 255271
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital /ID# 266364
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital /ID# 252734
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust /ID# 253988
    • Essex
      • Basingstoke, Essex, United Kingdom, RG24 9NA
        • Hampshire Hospitals NHS Foundation Trust /ID# 261416
    • Lancashire
      • Bury, Lancashire, United Kingdom, BL9 7TD
        • Northern Care Alliance NHS Foundation Trust /ID# 253993
    • Northamptonshire
      • Kettering, Northamptonshire, United Kingdom, NN16 8UZ
        • Kettering General Hospital NHS Foundation Trust /ID# 255263
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham City Hospital /ID# 255270
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals - John Radcliffe Hospital /ID# 265343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with moderately to severely active Ulcerative colitis (UC)

Description

Inclusion Criteria:

  • Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
  • Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
  • Participants prescribed upadacitinib in accordance with the approved local label.
  • Participants able to understand and communicate with the investigator and comply with the requirements of the study.
  • Participants willing to continue with study documentation after cessation of upadacitinib.
  • Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).

Exclusion Criteria:

  • Participants with any contraindication to upadacitinib.
  • Participants previously exposed to upadacitinib in a clinical trial.
  • Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants receiving upadacitinib
Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Achieve the First Clinical Response (CR) per Partial Adapted Mayo Score
Time Frame: Up to approximately week 156
The first clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score [RBS] ≥ 1 or absolute RBS ≤ 1. Median time to achieve the first CR per partial adapted mayo score will be reported
Up to approximately week 156
Percentage of Participants Achieving Clinical Response (CR) per Partial Adapted Mayo Score Among those who Achieved CR at Completion of Upadacitinib Induction (either at Week 8 or at Week 16)
Time Frame: Week 52
Clinical response (CR) per partial adapted mayo score is defined as a decrease from baseline in partial adapted mayo score ≥ 1 point and ≥ 30%, plus a decrease from baseline in the rectal bleeding score [RBS] ≥ 1 or absolute RBS ≤ 1.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P22-921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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