Health Trials

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

ConditionsUlcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSpyre Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening

Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)

Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2

Disqualifiers

Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined

Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction

Failed 4 or more approved or investigational advanced therapy classes

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPY001

    Drug

    Experimental

  • SPY002

    Drug

    Experimental

  • SPY003

    Drug

    Experimental

  • Placebo

    Other intervention

    Placebo

Treatment groups

645 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: Intervention Specific Appendix - SPY001: Part AExperimental treatment 1 intervention
Group B: Intervention Specific Appendix - SPY002: Part AExperimental treatment 1 intervention
Group C: Intervention Specific Appendix - SPY003: Part AExperimental treatment 1 intervention
Group D: Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part BExperimental treatment 1 intervention
Group E: Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part BExperimental treatment 1 intervention
Group F: Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part BExperimental treatment 1 intervention
Group G: Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part BExperimental treatment 1 intervention
Group H: Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part BExperimental treatment 1 intervention
Group I: Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part BExperimental treatment 1 intervention
Group J: Intervention Specific Appendix - SPY120: Part BExperimental treatment 2 interventions
Group K: Intervention Specific Appendix - SPY130: Part BExperimental treatment 2 interventions
Group L: Intervention Specific Appendix - SPY230: Part BExperimental treatment 2 interventions
Group M: Placebo: Part BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Change in Robarts Histopathology Index (RHI)

Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.

Time frame
Week 12
2

Part B: Percentage of participants with clinical remission

Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.

Time frame
Week 12

Secondary outcomes

1

Part A: Percentage of participants with clinical remission

Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.

Time frame
Week 12
2

Part A: Percentage of participants with endoscopic improvement

Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.

Time frame
Week 12
3

Part B: Percentage of participants with endoscopic improvement

Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.

Time frame
Week 12
4

Part B: Percentage of participants with clinical response

Percentage of participants with clinical response at Week 12 will be assessed. Clinical response is based on the modified Mayo Score, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spyre Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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