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Crohn's DiseaseUPliftNCT05930275

Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

An observational study of Crohn's Disease, run by AbbVie at 180 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
How many people
1,200 participants
Where
180 sitesin 17 countries
Study dates
19 Feb 2024to Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants with Crohn's disease (CD)

Who may be able to join

  • A diagnosis of moderate-to-severe crohn's disease (CD).
  • 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.
  • Able to understand and communicate with the investigator and comply with the requirements of the study.
  • Willing to continue with study documentation after cessation of upadacitinib.
  • Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app.

Who cannot join

  • Any contraindication to upadacitinib.
  • Previously exposure to upadacitinib in a clinical trial.
  • Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation).
  • Initiation of upadacitinib prior to enrollment.

Trial locations and contacts

180 sites in 17 countries.

180 sites in 17 countries

Japan34 sites

  • Asahikawa Medical University Hospital /ID# 266062

    Asahikawa-shi, Hokkaido, 078-8510

  • Asahikawa Medical University Hospital /ID# 269111

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical And Dental University Hospital /ID# 266081

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 266080

    Chiba, Chiba, 260-8677

  • Kyushu University Hospital /ID# 266100

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital /ID# 266099

    Fukuoka, 814-0180

  • Fukushima Medical University Hospital /ID# 266071

    Fukushima, Fukushima, 960-1295

  • Hamamatsu University Hospital /ID# 266090

    Hamamatsu, Shizuoka, 431-3192

  • Kansai Medical University Hospital /ID# 266095

    Hirakata-shi, Osaka, 573-1191

  • Hirosaki University Hospital /ID# 266065

    Hirosaki, Aomori, 036-8563

  • Hiroshima University Hospital /ID# 266098

    Hiroshima, 734-8551

  • Iwate Medical University - Yahaba Campus /ID# 266067

    Hizume, Iwate, 028-3694

  • Saitama Medical Center /ID# 266078

    Kawagoe, Saitama, 350-8550

  • University Hospital Kyoto Prefectural University of Medicine /ID# 268258

    Kyoto, Kyoto, 602-8566

  • Kitasato University Kitasato Institute Hospital /ID# 266084

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 266086

    Mitaka-shi, Tokyo, 181-8611

  • Nagoya University Hospital /ID# 266092

    Nagoya, Aichi-ken, 466-8560

  • Hyogo Medical University Hospital /ID# 266097

    Nishinomiya, Hyōgo, 663-8501

  • Osaka Police Hospital /ID# 266096

    Osaka, 543-0035

  • Shiga University of Medical Science /ID# 266094

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital /ID# 267884

    Saga, Saga-ken, 849-8501

  • Toho University Sakura Medical Center /ID# 266079

    Sakura, Chiba, 285-0841

  • Sapporo Medical University Hospital /ID# 265042

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital /ID# 266063

    Sapporo, Hokkaido, 060-8648

  • Sapporo Kosei General Hospital /ID# 266069

    Sapporo, 060-0033

  • Jichi Medical University Hospital /ID# 266077

    Shimotsuke-shi, Tochigi, 329-0498

  • Keio University Hospital /ID# 266085

    Shinjuku-ku, Tokyo, 160-8582

  • The Jikei University School of Medicine /ID# 266083

    Tokyo, 105-8461

  • Tokyo Yamate Medical Center /ID# 266082

    Tokyo, 169-0073

  • Toyama University Hospital /ID# 266089

    Toyama, 930-0194

  • Toyama Prefectural Central Hospital /ID# 266088

    Toyama, 930-0975

  • Fujita Health University Hospital /ID# 266091

    Toyoake, Aichi-ken, 470-1192

  • University of Tsukuba Hospital /ID# 266075

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Medical Center /ID# 266087

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

France27 sites

  • CHU Amiens-Picardie Site Sud /ID# 259121

    Amiens, Somme, 80054

  • Centre Hospitalier de la Cote Basque /ID# 259297

    Bayonne, Pyrenees-Atlantiques, 64100

  • Pole Sante Saint-Jean /ID# 259296

    Cagnes-sur-Mer, 06800

  • Ch Chalons En Champagne /Id# 259344

    Châlons-en-Champagne, Marne, 51000

  • Centre Hospitalier de CHOLET /ID# 259288

    Cholet, 49300

  • CHU Clermont-Ferrand /ID# 259294

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopital Beaujon /ID# 259287

    Clichy, Île-de-France Region, 92110

  • Chu Dijon /Id# 265910

    Dijon, Bourgogne-Franche-Comté, 21000

  • CH DREUX - Hopital Victor Jousselin /ID# 258635

    Dreux, 28102

  • AP-HP - Hopital Bicetre /ID# 259118

    Le Kremlin-Bicêtre, Paris, 94270

  • CHRU Lille - Hopital Claude Huriez /ID# 259302

    Lille, Nord, 59037

  • Hopital Edouard Herriot /ID# 266844

    Lyon, Auvergne-Rhône-Alpes, 69003

  • APHM - Hopital Nord /ID# 259304

    Marseille, Bouches-du-Rhone, 13015

  • Clinique Beau Soleil /ID# 259289

    Montpellier, Herault, 34070

  • CHU de Montpellier - Hopital Saint Eloi /ID# 269938

    Montpellier, Herault, 34295

  • CHU de Nantes, Hotel Dieu -HME /ID# 259293

    Nantes, Pays de la Loire Region, 44000

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339

    Neuilly-sur-Seine, Île-de-France Region, 92200

  • Chu de Nice-Hopital L'Archet Ii /Id# 261060

    Nice, Alpes-Maritimes, 06202

  • AP-HP - Hopital Saint-Antoine /ID# 259116

    Paris, 75012

  • Centre Hospitalier Universitaire de Bordeaux /ID# 259298

    Pessac, Gironde, 33604

  • CHRU Pontchaillou /ID# 259347

    Rennes, 35033

  • Cabinet du docteur Médina Boualit /ID# 259291

    Saint-Amand-les-Eaux, Nord, 59230

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 259303

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

  • CHU de Strasbourg /ID# 259343

    Strasbourg, 67091

  • CHU Toulouse - Hopital Rangueil /ID# 258636

    Toulouse, Haute-Garonne, 31400

  • GH Mutualiste Les Portes Du Sud /ID# 259299

    Vénissieux, Rhone, 69200

  • Hôpital Nord Ouest - Villefranche-sur-Saône /ID# 266999

    Villefranche-sur-Saône, Rhone, 69655

Other trials in France

Germany18 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 264097

    Berlin, 10117

  • Gastro Studien GbR /ID# 264617

    Berlin, 10825

  • Krankenhaus Waldfriede /ID# 264616

    Berlin, 14163

  • Praxis S. Tetzlaff /ID# 264613

    Buedelsdorf, Schleswig-Holstein, 24782

  • Medizinisches Versorgungszentrum Dachau /ID# 273294

    Dachau, Bavaria, 85221

  • Dr. Janschek /ID# 273218

    Dresden, 01309

  • SKH Studien GmbH /ID# 256100

    Hamburg, 20354

  • Private Practice - Dr. Matthias Eichler /ID# 256105

    Hamburg, 22041

  • Medizinische Hochschule Hannover /ID# 256109

    Hanover, 30625

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434

    Herne, 44623

  • Universitaetsklinikum Jena /ID# 273284

    Jena, Thuringia, 07743

  • Praxis fuer Gastroenterologie /ID# 256106

    Lübeck, Schleswig-Holstein, 23560

  • Klinikum Lueneburg /ID# 256107

    Lüneburg, Lower Saxony, 21339

  • Gastropraxis Magdeburg /ID# 266789

    Magdeburg, 39104

  • Dres. Kamp & Partner /ID# 267560

    Minden, North Rhine-Westphalia, 32423

  • Praxis Dres Brendel /ID# 256103

    Nuremberg, 90449

  • Verein für Wissenschaft und Forschung /ID# 265880

    Oldenburg, Lower Saxony, 26123

  • Praxis Dr. Kempelmann /ID# 256110

    Tostedt, 21255

Other trials in Germany

Canada15 sites

  • Barrie GI Associates /ID# 268436

    Barrie, Ontario, L4M 7G1

  • Foothills Medical Centre /ID# 263475

    Calgary, Alberta, T2N 2T9

  • Dr. J Siffledeen Profess Pract /ID# 262713

    Edmonton, Alberta, T6L 6K3

  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 262764

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Center- University Hospital /ID# 262693

    London, Ontario, N6A 5W9

  • West GTA Endoscopy /ID# 262946

    Mississauga, Ontario, L5M 2S4

  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264

    Montreal, Quebec, H1T 2M4

  • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262692

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials Inc /ID# 262347

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 262060

    North Bay, Ontario, P1B 2H3

  • Toronto Immune and Digestive Health Institute Inc /ID# 262540

    North York, Ontario, M6A 3B4

  • ABP Research Services Corp. /ID# 263111

    Oakville, Ontario, L6L 5L7

  • Diex Recherche Quebec Inc. /ID# 268256

    Québec, G1V 4T3

  • Toronto Digestive Disease Associates /ID# 262050

    Vaughan, Ontario, L4L 4Y7

  • University of Manitoba & Shared Health /ID# 265853

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Spain12 sites

  • Hospital Universitari Vall d'Hebron /ID# 263463

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 263461

    Córdoba, Cordoba, 14004

  • Hospital Galdakao-Usansolo /ID# 263458

    Galdakao, Vizcaya, 48960

  • Hospital Universitario Virgen de las Nieves /ID# 264206

    Granada, 18014

  • Hospital Jerez De La Frontera /ID# 273598

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263462

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Universitario Severo Ochoa /ID# 263933

    Leganés, Madrid, 28911

  • Hospital Universitario de La Princesa /ID# 263464

    Madrid, 28006

  • Hospital General Universitario Reina Sofía /ID# 264205

    Murcia, 30003

  • Hospital Universitario Central de Asturias /ID# 263457

    Oviedo, Principality of Asturias, 33011

  • Hospital Alvaro Cunqueiro /ID# 263460

    Pontevedra, 36312

  • Hospital de Sant Joan Despí Moisès Broggi /ID# 263936

    Sant Joan Despí, Barcelona, 08970

Other trials in Spain

Romania11 sites

  • Fundeni Clinical Institute /ID# 260354

    Bucharest, Bucharest, 022328

  • Fundeni Clinical Institute /ID# 260356

    Bucharest, Bucharest, 022328

  • Fundeni Clinical Institute /ID# 264021

    Bucharest, Bucharest, 022328

  • Spitalul Universitar de Urgență București /ID# 263763

    Bucharest, Bucharest, 050098

  • Spitalul Universitar de Urgență București /ID# 264025

    Bucharest, Bucharest, 050098

  • Spitalul Clinic Colentina /ID# 260355

    Bucharest, 020121

  • Gastromond /ID# 263770

    Constanța, 900635

  • Spitalul Clinic Judetean de Urgenta Craiova /Id# 264023

    Craiova, Dolj, 200642

  • Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264022

    Iași, 700111

  • Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264024

    Iași, 700111

  • Cabinet Particular Policlinic Algomed /ID# 260353

    Timișoara, 300002

Other trials in Romania

Greece10 sites

  • University General Hospital of Alexandroupoli /ID# 270161

    Alexandroupoli, Evros, 68100

  • Evangelismos Hospital /ID# 268132

    Athens, Attica, 10676

  • General Hospital of Athens G. Gennimatas /ID# 271501

    Athens, Attica, 11527

  • General Hospital of Athens Ippokratio /ID# 270248

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 266262

    Athens, Attica, 11527

  • Sotiria Thoracic Diseases Hospital of Athens /ID# 264352

    Athens, 11527

  • General Hospital of Athens Alexandra /ID# 266261

    Athens, 11528

  • General State Hospital of Nikaia /ID# 264351

    Athens, 14455

  • University General Hospital of Heraklion /ID# 266260

    Heraklion, Crete, 71500

  • Hippokration General Hospital of Thessaloniki /ID# 264353

    Thessaloniki, 54642

Other trials in Greece

Bulgaria9 sites

  • Gastro Med EOOD /ID# 267777

    Pazardzhik, Plovdiv, 4400

  • Umbal Kaspela /ID# 267562

    Plovdiv, 4001

  • ET dr Nikolay Tsonev /ID# 267584

    Samokov, Sofia, 2000

  • Diagnostic consultative center Focus-5 /ID# 267576

    Sofia, 1463

  • Diagnostic consultative center Focus-5 /ID# 268600

    Sofia, 1463

  • MC Higia HB /ID# 267575

    Sofiya, Sofia, 1700

  • AIPSMP dr Mirchev EOOD /ID# 267583

    Varna, 9000

  • MC Nadejda Femily EOOD /ID# 267585

    Varna, 9002

  • DCC Mladost M /ID# 267586

    Varna, 9009

Other trials in Bulgaria

China9 sites

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873

    Beijing, Beijing Municipality, 100730

  • West China Hospital of Sichuan University /ID# 265674

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital /ID# 270703

    Chengdu, Sichuan, 610072

  • Chongqing General Hospital /ID# 268384

    Chongqing, Chongqing Municipality, 400013

  • The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 265673

    Guangzhou, Guangdong, 510655

  • Jinhua Central Hospital /ID# 265871

    Jinhua, Zhejiang, 321000

  • Nanjing Drum Tower Hospital /ID# 266205

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital /ID# 266869

    Shanghai, Shanghai Municipality, 200025

Other trials in China

Italy8 sites

  • IRCCS Ospedale San Raffaele /ID# 268426

    Milan, Milano, 20132

  • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 268732

    Monserrato, Cagliari, 09042

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 269589

    Monza, Monza E Brianza, 20052

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 275093

    Palermo, 90127

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 268759

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 268731

    Rozzano, Lombardy, 20089

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 269224

    San Giovanni Rotondo, Foggia, 71013

  • A.O. Ordine Mauriziano di Torino /ID# 269231

    Turin, Torino, 10128

Other trials in Italy

Australia7 sites

  • Blacktown Hospital /ID# 258574

    Blacktown, New South Wales, 2148

  • Monash Health - Monash Medical Centre /ID# 258538

    Clayton, Victoria, 3168

  • Ibd Sa /Id# 268335

    Kurralta Park, South Australia, 5037

  • Macquarie University Hospital /ID# 268722

    Macquarie University, New South Wales, 2109

  • The Alfred Hospital /ID# 258537

    Melbourne, Victoria, 3004

  • Mater Misericordiae Limited /ID# 258535

    South Brisbane, Queensland, 4101

  • The Queen Elizabeth Hospital /ID# 258536

    Woodville South, South Australia, 5011

Other trials in Australia

Hungary5 sites

  • Semmelweis Egyetem /ID# 258515

    Budapest, 1085

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156

    Budapest, 1134

  • Debreceni Egyetem-Klinikai Kozpont /ID# 258518

    Debrecen, Hajdú-Bihar, 4032

  • Szegedi Tudományegyetem /ID# 258514

    Szeged, 6720

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517

    Szombathely, Vas County, 9700

Other trials in Hungary

Netherlands4 sites

  • OLVG - Locatie Oost /ID# 267099

    Amsterdam, North Holland, 1091 AC

  • Amsterdam UMC, locatie AMC /ID# 253970

    Amsterdam, North Holland, 1105 AZ

  • Radboudumc /ID# 264659

    Nijmegen, Gelderland, 6525 GA

  • Elisabeth TweeSteden Ziekenhuis /ID# 265898

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Czechia3 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 268351

    Brno, Brno-mesto, 625 00

  • SurGal Clinic /ID# 268757

    Brno, South Moravian, 602 00

  • Nemocnice Ceske Budejovice /ID# 264492

    České Budějovice, 370 01

Other trials in Czechia

Estonia3 sites

  • West Tallinn Central Hospital /ID# 270144

    Tallinn, Harju, 10617

  • East Tallinn Central Hospital - Magdaleena Unit /ID# 266653

    Tallinn, Harju, 11312

  • Tartu University Hospital /ID# 270148

    Tartu, Tartu, 50406

Other trials in Estonia

Ireland3 sites

  • Portiuncula University Hospital /ID# 268856

    Ballinasloe, Galway, H53 T971

  • St. Vincent's University Hospital /ID# 265638

    Dublin, D04 T6F4

  • Connolly Hospital /ID# 266388

    Dublin, D15 X40D

Other trials in Ireland

Denmark2 sites

  • Herlev Hospital /ID# 262487

    Herlev, Capital Region, 2730

  • Hvidovre Hospital /ID# 262613

    Hvidovre, Capital Region, 2650

Other trials in Denmark

About this study

Official title: A Multi-country, Prospective, Post-marketing Study of UPadacitinib Evaluating Speed of Onset and Durability of Effectiveness for Patients With Moderate to Severe Crohn's Disease for 3 Years in Real-world Clinical Practice (UPlift)

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world.

Read more

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. Study visits may be conducted on-site or virtually as per standard of care.

Conditions
Crohn's Disease
Keywords
Crohn's disease, CD, Upadacitinib
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05930275
Study groupRoleWhat they receive
UpadacitinibParticipants will receive upadacitinib as prescribed by their physician according to local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)

    Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or >= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as >= 30% decrease in average daily very soft or liquid SF and/or >= 30% decrease in average daily AP score and both not worse than baseline.

    Measured: Up to Week 12

  2. Percentage of Participants Achieving Clinical Remission per Harvey Bradshaw Index (HBI) Among those with Clinical Response-Harvey Bradshaw Index (CR-HBI) at End of Induction Therapy

    Clinical Remission is defined as HBI <= 4. Clinical Response is defined as HBI reduction >= 3 points from baseline. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.

    Measured: At Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start19 Feb 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05930275
Sponsor's protocol ID
P23-899
Acronym
UPlift
Status last verified
Jul 2025
First submitted
27 Jun 2023
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie at 180 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in Japan, France, Germany, Canada, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) (time frame: Up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05930275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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