Comparing AVT16 and Entyvio for treating ulcerative colitis

Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis

This study is testing whether a new treatment called AVT16 works better than the current medication Entyvio for people with moderate to severe ulcerative colitis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 748 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Alvotech Swiss AG (industry)
• Locations: 100 sites (Ciudad Autónoma de BuenosAires and 99 other locations)
• Trial ID: NCT06570772 on ClinicalTrials.gov

What this trial studies

This study is a randomized, parallel-group, double-blind, phase 3 trial designed to compare the efficacy, safety, and immunogenicity of AVT16 and Entyvio in patients with moderate to severe active ulcerative colitis. Participants will undergo a screening period to determine eligibility, followed by randomization into one of two treatment groups. The study will include a treatment and assessment period, concluding with an End of Study visit to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are male and female adults aged 18 to 80 with a diagnosis of ulcerative colitis.

Not a fit: Patients with Crohn's colitis, extensive colonic resection, or active or latent tuberculosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from moderate to severe ulcerative colitis.

How similar studies have performed: Other studies have shown success with similar biologic treatments for ulcerative colitis, indicating potential for positive outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

* Capable of giving signed informed consent
* Male and female subjects from 18 to 80 years of age
* Diagnosis of Ulcerative Colitis

Exclusion Criteria:

* Diagnosis of Crohn's colitis
* Extensive colonic resection
* Active or latent tuberculosis

Where this trial is running

Ciudad Autónoma de BuenosAires and 99 other locations

• Investigational Site 161704 — Ciudad Autónoma de BuenosAires, Argentina (NOT_YET_RECRUITING)
• Investigational Site 161702 — Cordoba, Argentina (NOT_YET_RECRUITING)
• Investigational Site 161701 — Quilmes, Argentina (NOT_YET_RECRUITING)
• Investigational Site 161705 — Tucumán, Argentina (NOT_YET_RECRUITING)
• Investigational Site 160111 — Burgas, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160102 — Pleven, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160109 — Ruse, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160101 — Sliven, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160103 — Sofia, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160105 — Sofia, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160108 — Sofia, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160107 — Stara Zagora, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160106 — Vratsa, Bulgaria (NOT_YET_RECRUITING)
• Investigational Site 160204 — Bjelovar, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160202 — Osijek, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160205 — Rijeka, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160206 — Slavonski Brod, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160202 — Zagreb, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160207 — Zagreb, Croatia (NOT_YET_RECRUITING)
• Investigational Site 160507 — Batumi, Georgia (NOT_YET_RECRUITING)
• Investigational Site 160501 — Tbilisi, Georgia (RECRUITING)
• Investigational Site 160502 — Tbilisi, Georgia (NOT_YET_RECRUITING)
• Investigational Site 160503 — Tbilisi, Georgia (NOT_YET_RECRUITING)
• Investigational Site 160505 — Tbilisi, Georgia (NOT_YET_RECRUITING)
• Investigational Site 160506 — Tbilisi, Georgia (RECRUITING)
• Investigational Site 160802 — Liepāja, Latvia (RECRUITING)
• Investigational Site 160801 — Riga, Latvia (RECRUITING)
• Investigational Site 160803 — Riga, Latvia (RECRUITING)
• Investigational Site 161025 — Bydgoszcz, Poland (RECRUITING)
• Investigational Site 161008 — Chojnice, Poland (RECRUITING)
• Investigational Site 161013 — Grudziądz, Poland (NOT_YET_RECRUITING)
• Investigational Site 161029 — Kielce, Poland (NOT_YET_RECRUITING)
• Investigational Site 161018 — Knurów, Poland (NOT_YET_RECRUITING)
• Investigational Site 161035 — Kraków, Poland (NOT_YET_RECRUITING)
• Investigational Site 1614011 — Ksawerów, Poland (RECRUITING)
• Investigational Site 161028 — Kłodzko, Poland (NOT_YET_RECRUITING)
• Investigational Site 161015 — Lublin, Poland (NOT_YET_RECRUITING)
• Investigational Site 161033 — Olsztyn, Poland (RECRUITING)
• Investigational Site 161021 — Piotrków Trybunalski, Poland (RECRUITING)
• Investigational Site 161022 — Poznań, Poland (NOT_YET_RECRUITING)
• Investigational Site 161023 — Rzeszów, Poland (RECRUITING)
• Investigational Site 161024 — Rzeszów, Poland (RECRUITING)
• Investigational Site 161009 — Sopot, Poland (RECRUITING)
• Investigational Site 161010 — Szczecin, Poland (RECRUITING)
• Investigational Site 161005 — Toruń, Poland (NOT_YET_RECRUITING)
• Investigational Site 161017 — Tychy, Poland (RECRUITING)
• Investigational Site 161007 — Warsaw, Poland (NOT_YET_RECRUITING)
• Investigational Site 161012 — Warsaw, Poland (RECRUITING)
• Investigational Site 161016 — Warsaw, Poland (RECRUITING)
• Investigational Site 161041 — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Richard Bucknall

Conditions: Ulcerative Colitis