A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

Official title

Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

Overview

Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis. This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years. Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Interventions

• Drug BI 3032950 intravenous (Part A)
  BI 3032950 intravenous (Part A)
• Drug BI 3032950 subcutaneous (Part B)
  BI 3032950 subcutaneous (Part B)

Primary outcome measures

• Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1 [Time frame: Up to Week 12]

Secondary outcome measures (7)

• Endoscopic remission (defined as centrally-read ESS of 0) [Time frame: Up to Week 12]
• Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1) [Time frame: Up to Week 12]
• Endoscopic improvement (defined as centrally-read ESS of 0 or 1) [Time frame: Up to Week 12]
• Modified Mayo Score change from baseline [Time frame: Up to Week 12]
• Stool frequency subscore of 0 or 1 [Time frame: Up to Week 12]
• Rectal bleeding subscore of 0 [Time frame: Up to Week 12]
• Occurrence of treatment-emergent adverse events (AEs) [Time frame: Up to Week 12 and up to Week 104]

Eligibility criteria

Inclusion criteria

• Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
• Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
• Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
• Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
• Further inclusion criteria apply.

Exclusion criteria

• Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
• Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
• Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
• Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
• Evidence of fulminant colitis or toxic megacolon at screening,
• Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
• Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
• Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
• Further exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 15 centers

• Centrum Medyczne Plejady — Krakow
• Medrise Sp. z o.o. — Lublin
• Eskulap Pabianice Sp. z o.o. — Pabianice
• EMC Instytut Medyczny S.A. - Poznan 70-304 — Poznan
• Clinical Research Center Sp. z o.o. Medic-R sp.k. — Poznan
• Centrum Medyczne Medyk Sp. z o.o. — Rzeszów
• Endoskopia Sp. z o.o. — Sopot
• Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. — Szczecin
• … and 7 more centers

United States · 14 centers

• One of a Kind Clinical Research Center — Scottsdale
• Peak Gastroenterology Associates — Colorado Springs
• Primary Care of Osceola — Kissimmee
• Florida Research Institute — Lakewood Rch
• University of Miami — Miami
• Reliant Medical Research — Miami
• Illinois Gastroenterology Group - Gurnee — Gurnee
• University of Kansas Medical Center — Kansas City
• … and 6 more centers

Serbia · 4 centers

• Clinical Hospital Center Zvezdara — Belgrade
• Military Medical Academy — Belgrade
• Clinical Center Zemun — Belgrade
• General Hospital - Djordje Joanovic — Zrenjanin

Slovakia · 4 centers

• F D Roosevelt University General Hospital Of Banska Bystrica — Banská Bystrica
• ENDOMED s.r.o. — Košice
• KM Management, spol. s.r.o. — Nitra
• Gastro I., s.r.o — Prešov

Belgium · 2 centers

• UZ Leuven — Leuven
• CHC MontLegia — Liège

Czechia · 2 centers

• Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové
• ISCARE a.s. — Prague

Identifiers

NCT: NCT06636656 · 1486-0006 · 2023-509544-10-00 · U1111-1300-3640

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗