Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

NCT07652294 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 2 other identifiers: SPY123-2022025-524640-35-00
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Keywords

Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of study drug treatment regimens

  Incidence of treatment-emergent adverse events (TEAEs)

  Week 96

Secondary Outcomes (1)

• To assess the efficacy of intervention at Week 48

  Week 48

Study Arms (10)

SPY001 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY001

Drug: SPY001

SPY002 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

SPY003 Dosing Regimen 1

EXPERIMENTAL

Participants will receive SPY003

Drug: SPY003

SPY001 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY001

Drug: SPY001

SPY002 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

SPY003 Dosing Regimen 2

EXPERIMENTAL

Participants will receive SPY003

Drug: SPY003

SPY001 & SPY002

EXPERIMENTAL

Participants will receive SPY001 and SPY002

Drug: SPY001; Drug: SPY002

SPY001 & SPY003

EXPERIMENTAL

Participants will receive SPY001 and SPY003

Drug: SPY001; Drug: SPY003

SPY002 & SPY003

EXPERIMENTAL

Participants will receive SPY002 and SPY003

Drug: SPY002; Drug: SPY003

SPY002 Dosing Regimen 3

EXPERIMENTAL

Participants will receive SPY002

Drug: SPY002

Interventions

SPY001 DRUG

Experimental

Also known as: SPY001-001

SPY001 & SPY002; SPY001 & SPY003; SPY001 Dosing Regimen 1; SPY001 Dosing Regimen 2

SPY002 DRUG

Experimental

Also known as: SPY002-091

SPY001 & SPY002; SPY002 & SPY003; SPY002 Dosing Regimen 1; SPY002 Dosing Regimen 2; SPY002 Dosing Regimen 3

SPY003 DRUG

Experimental

Also known as: SPY003-207

SPY001 & SPY003; SPY002 & SPY003; SPY003 Dosing Regimen 1; SPY003 Dosing Regimen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet 1 of the following criteria from Study SPY123-201:
• Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
• Completed Part B
• Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period \[ITP\] or experienced disease worsening during the maintenance treatment period \[MTP\]).

You may not qualify if:

• Met any treatment discontinuation criteria from Study SPY123-201.
• Is on any of the following prohibited medications:
• Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
• Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects
• Any marketed advanced therapy (ie, biologic or small molecule)
• Any investigational therapy other than SPY123-201 study drug
• Total parenteral nutrition
• Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
• Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Sponsors & Collaborators

• Spyre Therapeutics, Inc.: lead

Study Sites (1)

Study Site 002

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• SKYLINE Study Director

  Spyre Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): March 2, 2029
• Study Completion (Estimated): January 3, 2030
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)