Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

NCT06127043 · View on ClinicalTrials.gov ↗

Study Summary

ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Rosnilimab

Study Locations (20)

Florida

  • AnaptysBio Investigational Site 10-127 — Brooksville
  • AnaptysBio Investigational Site 10-106 — Miami
  • AnaptysBio Investigational Site 10-109 — Miami Gardens
  • AnaptysBio Investigational Site 10-131 — Orlando
  • AnaptysBio Investigational Site 10-123 — Orlando
  • AnaptysBio Investigational Site 10-125 — Tampa

California

  • AnaptysBio Investigational Site 10-117 — Garden Grove
  • AnaptysBio Investigational Site 10-112 — Lancaster
  • AnaptysBio Investigational Site 10-129 — Lancaster
  • AnaptysBio Investigational Site 10-108 — San Jose

Texas

  • AnaptysBio Investigational Site 10-104 — Dallas
  • AnaptysBio Investigational Site 10-113 — Garland

Arizona

  • AnaptysBio Investigational Site 10-115 — Phoenix

Georgia

  • AnaptysBio Investigational Site 10-122 — Atlanta

Illinois

  • AnaptysBio Investigational Site 10-124 — Oak Lawn

Nevada

  • AnaptysBio Investigational Site 10-118 — Las Vegas

New York

  • AnaptysBio Investigational Site 10-133 — Utica

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2023-12-04
Est. Completion 2026-05
Phase Phase 2

Sponsor

AnaptysBio

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06127043

The ClinicalTrials.gov registry entry for NCT06127043 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AnaptysBio, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06127043 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06127043 about?

NCT06127043 is a clinical study titled "A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)". ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

What is the current status of trial NCT06127043?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2023-12-04. Estimated completion is 2026-05.

What conditions does trial NCT06127043 study?

This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06127043?

The interventions under investigation include: Placebo (DRUG), Rosnilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06127043?

This trial is sponsored by AnaptysBio, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06127043 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial