Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combination for Inflammatory Bowel Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Spyre Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-06-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Spyre Therapeutics, Inc.

External identifiers

EU CT number

2025-524640-35-00

WHO UTN

U1111-1331-4790

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

To assess the safety and tolerability of study drug treatment regimens

Secondary objectives 1

1. To assess the efficacy of intervention at Week 48

Conditions and MedDRA coding

Ulcerative colitis (Inflammatory Bowel Disease)

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Participants must meet 1 of the following criteria from Study SPY123-201: a. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator b. Completed Part B c. 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]).

Exclusion criteria 4

1. 1. Met any treatment discontinuation criteria from Study SPY123-201.
2. 2. Is on any of the following prohibited medications: a. Immunosuppressants (eg, azathioprine, 6-MP, or methotrexate) b. 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 c. Any marketed advanced therapy (ie, biologic or small molecule) d. Any investigational therapy other than SPY123-201 study drug e. Total parenteral nutrition
3. 3. 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. This includes any clinically significant abnormalities in laboratory (such as ALT or AST>3×ULN, total white blood cell count [WBC]<1000/µL, and absolute neutrophil count [ANC]<500/µL), vital signs, or ECG (such as a prolongation of QTcF interval ≥450 msec for males and ≥470 msec for females) during the last evaluation of Study SPY123-201 which, in the opinion of the Investigator, may suggest that participation is not in the best interest of the participant, confound study results, or interfere with the study conduct or compliance. Note that for laboratory or ECG abnormalities, a retest can be performed once during the LTE Eligibility Period, as per Investigator judgement.
4. 4. Ongoing infection requiring oral or IV antimicrobial therapy on Day 1.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of TEAEs (treatment-emergent adverse event)

Secondary endpoints 1

1. Endoscopic improvement at Week 48

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Spyre Therapeutics Inc.

Sponsor organisation

Spyre Therapeutics Inc.

Address

221 Crescent Street Building 23 Suite 105

City

Waltham

Postcode

02453-3425

Country

United States

Scientific contact point

Organisation

Spyre Therapeutics Inc.

Contact name

SKYLINE-UC Trial Center

Public contact point

Organisation

Spyre Therapeutics Inc.

Contact name

SKYLINE-UC Trial Center

Third parties 11

Locations

14 EU/EEA countries · 111 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 82 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications