Clinical trial NCT06636656: A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Official title: Phase IIa, Single-arm, 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study consists of Part A and Part B.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: 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
timeFrame: Up to Week 12
Secondary outcomes:
measure: Endoscopic remission (defined as centrally-read ESS of 0)
timeFrame: Up to Week 12
measure: 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)
timeFrame: Up to Week 12
measure: Endoscopic improvement (defined as centrally-read ESS of 0 or 1)
timeFrame: Up to Week 12
measure: Modified Mayo Score change from baseline
timeFrame: Up to Week 12
measure: Stool frequency subscore of 0 or 1
timeFrame: Up to Week 12
measure: Rectal bleeding subscore of 0
timeFrame: Up to Week 12
measure: Occurrence of treatment-emergent adverse events (AEs)
timeFrame: Up to Week 12 and up to Week 104
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: New Haven
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research
state: Florida
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group - Gurnee
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cedar Park
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Mansfield
country: United States
facility: GI Alliance
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Clinique CHC Montlégia
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Medis
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Lodz
country: Poland
facility: Eskulap Pabianice Sp. Z o.o.
city: Lublin
country: Poland
facility: Medrise Sp. z o.o.
city: Poznan
country: Poland
facility: EMC Instytut Medyczny S.A.-Poznan-70304
city: Poznan
country: Poland
facility: Clinical Research Center
city: Rzeszow
country: Poland
facility: Medical Center Medyk
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: Gastromed Sp. z o.o.
city: Warsaw
country: Poland
facility: Non-Public Outpatient Medical Care VIVAMED, Warsaw
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
city: Wroclaw
country: Poland
facility: PlanetMed Sp. z o.o.
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A.-Wroclaw-70301
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr. Dragisa Misovic
city: Belgrade
country: Serbia
facility: Clinical Medical Center Zvezdara, Belgrade
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: University Clinical Center of Kragujevac
city: Zrenjanin
country: Serbia
facility: General Hospital - Djordje Joanovic
city: Banska Bystrica
country: Slovakia
facility: FNsP F.D.R. Banska Bystrica
city: Kosice
country: Slovakia
facility: ENDOMED s.r.o.
city: Nitra
country: Slovakia
facility: KM Management, spol. s.r.o.
city: Presov
country: Slovakia
facility: Gastro I., s.r.o
city: Sahy
country: Slovakia
facility: Accout Center s.r.o.
Study officials:
References: