臨床研究等提出・公開システム

Date of registration	April. 01, 2026
Last modified on	April. 01, 2026
Trial ID	jRCT2031260002

Scientific Title	Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
Public Title	Phase 2 Platform Trial of Long-acting Antibodies for Moderately to Severely Active Ulcerative Colitis

Contact for Scientific Queries	Name	Nguyen Deanna
	Affiliation	Spyre Therapeutics, Inc.
	Address	221 Crescent St Building 23, Suite 105 Waltham, MA 02453 USA
	Telephone	831-421-1450
	E-mail	deanna.nguyen@spyre.com
Contact for Public Queries	Name	Kaji Sayaka
	Affiliation	PSI CRO Japan K.K.
	Address	Hanshin Building 6F, 1-13-21 Nihonbashi Kayabacho, Chuo-ku, Tokyo 103-0025, Japan
	Telephone	+81-3-6821-2417
	E-mail	psij_clinical-trials@psi-cro.com

Recruitment status	Pending

Anticipated date of first enrollment		April. 01, 2026
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative Colitis
Intervention(s)		Subjects will be randomized in a blinded manner to one of the following groups: monotherapy groups with three investigational products (SPY001, SPY002, or SPY003), combination therapy groups consisting of two of these agents, SPY120 (SPY001 + SPY002), SPY130 (SPY001 + SPY003), or SPY230 (SPY002 + SPY003) or a placebo group. Each of he three monotherapy groups includes both a high-dose group and a low-dose group. After randomization, during the initial 12 week induction treatment period, the assigned investigational product will be administered intravenously at Weeks 0, 4, and 12. Thereafter, the same investigational product will be administered subcutaneously at Weeks 24 and 36 in 36 week maintenance treatment period.
Primary Outcome(s)		Clinical remission at Week12
Secondary Outcome(s)		Endoscopic improvement at Week 12 Clinical response at Week 12 Histologic improvement at Week 12 HEMI at Week 12 Clinical remission at Week 48 Study drug concentration through Week 12 Percentage of participants with ADA to study drugs through Week 12 Safety and tolerability of intervention through Week 12 Safety and tolerability of intervention from Week 12 dosing through Week 48 and last follow up visit (if applicable)

Primary Sponsor	Spyre Therapeutics, Inc.

Name of Certified Review Board	Institutional Review Board, Juntendo University Urayasu Hospital
Address	2-1-1 Tomioka, Urayasu-shi, Chiba, Chiba
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	Argentina/Australia/Austria/Belgium/Bosnia and Herzegovina/Brazil/Bulgaria/Canada/Chile/China/Croatia/Czech Republic/France/Georgia/Germany/Greece/Hungary/India/Israel/Italy/Jordan/Kazakhstan/Lithuania/Mexico/Moldova/Poland/Romania/Serbia/Slovakia/South Korea