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Ulcerative ColitisNCT06764706

Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis

An observational study of Ulcerative Colitis, run by AbbVie at 57 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
How many people
200 participants
Where
57 sitesGermany
Study dates
27 Feb 2025to Jul 2028
Phase
Observational

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 moderate to severe ulcerative colitis being treated with risankizumab.

Who may be able to join

  • Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
  • Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.

Who cannot join

  • Participants previously exposed risankizumab
  • Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).

Trial locations and contacts

57 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical Information Germany contact

49 611 1720 1520

medinfo.germany@abbvie.com

57 sites in 1 country

Germany57 sites, 57 recruiting

  • Medizinisches Versorgungszentrum Ahaus /ID# 280966

    Ahaus, North Rhine-Westphalia, 48683

    Recruiting

  • Klinikum Altenburger Land /ID# 283912

    Altenburg, Thuringia, 04600

    Recruiting

  • Gemeinschaftspraxis im Medicum /ID# 275933

    Altenholz, Schleswig-Holstein, 24161

    Recruiting

  • Praxis Heil & Mueller /ID# 275927

    Andernach, 56626

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884

    Berlin, 10117

    Recruiting

  • Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966

    Berlin, 10318

    Recruiting

  • Private Practice- Dr. Andreas Horn /ID# 281448

    Berlin, 10369

    Recruiting

  • Gastroenterologie im Muhlenbergviertel /ID# 275883

    Berlin, 10409

    Recruiting

  • Dres. Schick/Wesenberg /ID# 275878

    Berlin, 10437

    Recruiting

  • Gastro Studien GbR /ID# 275920

    Berlin, 10825

    Recruiting

  • Drk Kliniken Berlin - Kopenick /ID# 276277

    Berlin, 12559

    Recruiting

  • Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089

    Berlin, 12683

    Recruiting

  • Praxis Dr. Soellenboehmer /ID# 276183

    Berlin, 14052

    Recruiting

  • Krankenhaus Waldfriede /ID# 275913

    Berlin, 14163

    Recruiting

  • Praxis Dr. Spitz /ID# 275912

    Berlin, 14163

    Recruiting

  • Gastropraxis Bochum /ID# 281375

    Bochum, North Rhine-Westphalia, 44787

    Recruiting

  • Katholisches Klinikum Bochum gGmbH /ID# 279486

    Bochum, North Rhine-Westphalia, 44791

    Recruiting

  • Praxis S. Tetzlaff /ID# 275882

    Buedelsdorf, Schleswig-Holstein, 24782

    Recruiting

  • Evangelisches Krankenhaus Kalk /ID# 276414

    Cologne, North Rhine-Westphalia, 51103

    Recruiting

  • Private Practice - Dr. Johannes Janschek /ID# 275877

    Dresden, Saxony, 01309

    Recruiting

  • Universitaetsklinikum Duesseldorf /ID# 280409

    Düsseldorf, North Rhine-Westphalia, 40225

    Recruiting

  • Dres. Bauer/Doerflinger /ID# 276093

    Freiburg im Breisgau, 79102

    Recruiting

  • Praxis Dr. Guenther-Tritsch /ID# 275886

    Geesthacht, Schleswig-Holstein, 21502

    Recruiting

  • Private Practice - Dr. Thomas Zeisler /ID# 277933

    Halle, Saxony-Anhalt, 06108

    Recruiting

  • Studiengesellschaft Mitteldeutschland /ID# 275905

    Halle, Saxony-Anhalt, 06108

    Recruiting

  • Private Practice - Dr. Matthias Eichler /ID# 275875

    Hamburg, 22041

    Recruiting

  • Gastroenterologie Rahlstedt /ID# 276408

    Hamburg, 22143

    Recruiting

  • Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701

    Hanover, Lower Saxony, 30449

    Recruiting

  • Diabetologie Dithmarschen /ID# 281104

    Heide, Schleswig-Holstein, 25746

    Recruiting

  • Universitaetsklinikum Heidelberg /ID# 275906

    Heidelberg, Baden-Wurttemberg, 69120

    Recruiting

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874

    Herne, 44623

    Recruiting

  • Dr. Jack Peter-Stein /ID# 276815

    Jena, Thuringia, 07743

    Recruiting

  • Praxisgemeinschaft Jerichow Schulze /ID# 275911

    Jerichow, Saxony-Anhalt, 39319

    Recruiting

  • Gastroenterologe am Ettlinger Tor /ID# 279854

    Karlsruhe, 76133

    Recruiting

  • Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931

    Kiel, Schleswig-Holstein, 24105

    Recruiting

  • Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943

    Koblenz, Rhineland-Palatinate, 56068

    Recruiting

  • Universitaetsklinikum Leipzig /ID# 276779

    Leipzig, Saxony, 04103

    Recruiting

  • Gesellschaft für klinische Studien /ID# 275867

    Leipzig, Saxony, 04105

    Recruiting

  • Dres. Breitschwerdt/Glas/Gurtler /ID# 276057

    Leipzig, 04107

    Recruiting

  • MVZ Gastroenterologie Leverkusen /ID# 275901

    Leverkusen, 51375

    Recruiting

  • Praxis fuer Gastroenterologie - Lubeck /ID# 275903

    Lübeck, Schleswig-Holstein, 23560

    Recruiting

  • Gastroenterologische Schwerpunkt Praxis /ID# 279856

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67071

    Recruiting

  • Gastropraxis Magdeburg /ID# 275885

    Magdeburg, 39104

    Recruiting

  • Dres. Kamp & Partner /ID# 275904

    Minden, North Rhine-Westphalia, 32423

    Recruiting

  • Bettenworth & Partner /ID# 275900

    Münster, 48149

    Recruiting

  • Fek - Friedrich-Ebert-Krankenhaus Neumunster /ID# 276105

    Neumünster, Schleswig-Holstein, 24534

    Recruiting

  • Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072

    Nordhausen, Thuringia, 99734

    Recruiting

  • Pc Docs /Id# 275876

    Pirmasens, 66953

    Recruiting

  • Klinikum Ernst Von Bergmann /ID# 278268

    Potsdam, Brandenburg, 14467

    Recruiting

  • Praxis fuer Gastroenterologie - Schwerin /ID# 275946

    Schwerin, Mecklenburg-Vorpommern, 19057

    Recruiting

  • Dres. Rehbehn/Skusa /ID# 276090

    Solingen, 42651

    Recruiting

  • Private Practice - Dr. Jaqueline Schumann /ID# 276126

    Teuchern, Saxony-Anhalt, 06682

    Recruiting

  • Private Practice - Dr. Kempelmann /ID# 275726

    Tostedt, Free and Hanseatic City of Hamburg, 21255

    Recruiting

  • Private Practice - Dr. Markus Braunfels /ID# 277129

    Wesseling, 50389

    Recruiting

  • Gemeinschaftspraxis Innere Medizin /ID# 280068

    Witten, North Rhine-Westphalia, 58445

    Recruiting

  • Private Practice Dr. Katharina Pfeifer /ID# 286373

    Wriezen, Brandenburg, 16269

    Recruiting

  • Dr. Schirin-Sokhan /ID# 276982

    Würselen, 52146

    Recruiting

Other trials in Germany

About this study

Official title: A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.

Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.

Read more

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

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.

Keywords
Ulcerative colitis, Risankizumab, SKYRIZI
Medical subject headings
Colitis, Ulcerative

What participants receive

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

Study groups in NCT06764706
Study groupRoleWhat they receive
RisankizumabParticipants will receive risankizumab 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. Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score

    Symptomatic remission is defined as stool frequency (SFS) <=1 and rectal bleeding subscore (RBS)=0

    Measured: Up to approximately 52 weeks

Timeline

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

  1. First posted8 Jan 2025
  2. Study start27 Feb 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764706
Sponsor's protocol ID
P25-544
Status last verified
Oct 2026
First submitted
3 Jan 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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