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

Spyre Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Colitis, Ulcerative; Colitis; Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Drug: SPY002; Drug: SPY001; Drug: SPY003; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07012395

SPY123-201

Details and patient eligibility

About

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.

Full description

This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts.

Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies.

Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo.

Intervention arms will be added to the study over time and may complete at different times.

Enrollment: 645 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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645 participants in 13 patient groups, including a placebo group

Intervention Specific Appendix - SPY001: Part A

Experimental group

Description:

Participants will receive open-label dose of SPY001

Treatment:

Drug: SPY001

Intervention Specific Appendix - SPY002: Part A

Experimental group

Description:

Participants will receive open-label dose of SPY002

Treatment:

Drug: SPY002

Intervention Specific Appendix - SPY003: Part A

Experimental group

Description:

Participants will receive open-label dose of SPY003

Treatment:

Drug: SPY003

Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 1 of SPY001

Treatment:

Drug: SPY001

Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 2 of SPY001

Treatment:

Drug: SPY001

Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 1 of SPY002

Treatment:

Drug: SPY002

Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 2 of SPY002

Treatment:

Drug: SPY002

Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 1 of SPY003

Treatment:

Drug: SPY003

Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B

Experimental group

Description:

Participants will receive double-blind dosing regimen 2 of SPY003

Treatment:

Drug: SPY003

Intervention Specific Appendix - SPY120: Part B

Experimental group

Description:

Participants will receive double-blind dose of SPY001 and SPY002

Treatment:

Drug: SPY002

Drug: SPY001

Intervention Specific Appendix - SPY130: Part B

Experimental group

Description:

Participants will receive double-blind dose of SPY001 and SPY003

Treatment:

Drug: SPY003

Drug: SPY001

Intervention Specific Appendix - SPY230: Part B

Experimental group

Description:

Participants will receive double-blind dose of SPY002 and SPY003

Treatment:

Drug: SPY003

Drug: SPY002

Placebo: Part B

Placebo Comparator group

Description:

Participants will receive matching placebo

Treatment:

Other: Placebo