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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

NCT07012395 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2026-05-19

No results posted yet for this study

Summary

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Conditions

Interventions

DRUG

SPY001

Experimental

DRUG

SPY002

Experimental

DRUG

SPY003

Experimental

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Spyre Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • SKYLINE-UC Study Director · Spyre Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2026-06-30
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Jordan
  • Lithuania
  • Moldova
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012395 on ClinicalTrials.gov