SPY001-001 for Moderately to severely active ulcerative colitis|Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- 1. Male or female ≥18 years of age."}
• {"criterion_text":"- 2. Adult participants must have had a diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening."}
• {"criterion_text":"- 3. Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy, with the exception of up to approximately 15% of the total population permitted to have only proctitis (<15 cm from the anal verge)."}
• {"criterion_text":"- 4. Moderately to severely active disease as defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2."}
• {"criterion_text":"- 5. History of corticosteroid dependence, OR inadequate response, OR loss of response OR intolerance to 1 of the following: a) conventional therapy only (oral locally acting or systemic corticosteroids, or immunosuppressants) (target of approximately 40%-60% of the planned sample size); OR b) approved advanced therapies, i.e.: anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, or S1P receptor antagonists) (target of approximately 40%-60% of the planned sample size)."}
• {"criterion_text":"- 6. Participants taking oral corticosteroids (up to 20 mg/day prednisone or equivalent, 9 mg/day budesonide, or 5 mg/day beclomethasone) must be on a stable dose for ≥2 weeks prior to Day 1 and be willing to stay on the same dose during the ITP (for Part A participants), or through Week 6 and initiate taper at Week 6 (for Part B participants)."}

Exclusion criteria

• {"criterion_text":"- 1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, and S1P receptor antagonists) at the approved labeled dose or higher, if applicable."}
• {"criterion_text":"- 2. Failed (inadequate response, loss of response, or intolerance to) 2 or more of the following classes (whether drug is approved or investigational) at an approved labeled dose or higher, if applicable: –\tanti-α4β7 (e.g., vedolizumab), –\tanti-TL1A, or –\tanti-IL-23 (eg, mirikizumab, guselkumab, risankizumab). Note that ustekinumab failure is not applicable to this exclusion criterion."}
• {"criterion_text":"- 3. Current diagnosis of Crohn’s disease or IBD-Undefined."}
• {"criterion_text":"- 4. History of colectomy (total, subtotal, partial) or ileostomy."}
• {"criterion_text":"- 5. If female, pregnant (including those with positive pregnancy test prior to randomization), breastfeeding, or lactating."}
• {"criterion_text":"- 6. History and/or current symptoms of infections, including TB, Chronic Hepatitis B or C, COVID-19, HIV, Clostridioides difficile toxin, herpes zoster and Cytomegalovirus."}
• {"criterion_text":"- 7. Intervention Specific Appendix-SPY001, Part A Only: Failure (inadequate response, loss of response, or intolerance) of vedolizumab as defined in Master Protocol Appendix 2."}

Primary endpoints

• {"endpoint_text":"- Part A: Change in RHI from baseline at Week 12.","definition_or_measurement_approach":"Change from baseline in RHI (histologic Robarts histopathology index) measured at Week 12 (assesses histologic disease activity)."}
• {"endpoint_text":"- Part B: Clinical remission at Week 12.","definition_or_measurement_approach":"Assessment of clinical remission at Week 12 using protocol-defined clinical remission criteria (as per study definitions)."}

Secondary endpoints

• {"endpoint_text":"- Part A: 1. Clinical remission at Week 12.","definition_or_measurement_approach":"Clinical remission assessed at Week 12 per protocol-defined criteria."}
• {"endpoint_text":"- Part A: 2. Endoscopic improvement at Week 12.","definition_or_measurement_approach":"Endoscopic assessment at Week 12 (Mayo endoscopic subscore improvement) as defined in protocol."}
• {"endpoint_text":"- Part A: 3. Change in modified Mayo score from baseline at Week 12.","definition_or_measurement_approach":"Change from baseline in modified Mayo score measured at Week 12."}
• {"endpoint_text":"- Part A: 4. Study drug concentration through Week 12.","definition_or_measurement_approach":"Pharmacokinetic measurements: study drug serum concentrations sampled through Week 12."}
• {"endpoint_text":"- Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12.","definition_or_measurement_approach":"Immunogenicity: proportion of participants with anti-drug antibodies measured through Week 12."}
• {"endpoint_text":"- Part B: 1. Endoscopic improvement at Week 12.","definition_or_measurement_approach":"Endoscopic assessment at Week 12 (protocol-defined endoscopic improvement)."}
• {"endpoint_text":"- Part B: 2. Clinical response at Week 12.","definition_or_measurement_approach":"Clinical response assessed at Week 12 per protocol-defined criteria."}
• {"endpoint_text":"- Part B: 3. Histologic improvement at Week 12.","definition_or_measurement_approach":"Histologic assessment for improvement at Week 12 (protocol-defined histology measures)."}
• {"endpoint_text":"- Part B: 4. HEMI at Week 12.","definition_or_measurement_approach":"Histologic endoscopic mucosal improvement (HEMI) assessed at Week 12 per protocol definition."}
• {"endpoint_text":"- Part B: 5. Clinical remission at Week 48.","definition_or_measurement_approach":"Clinical remission assessed at Week 48 per protocol-defined criteria."}
• {"endpoint_text":"- Part B: 6. Study drug concentration through Week 12.","definition_or_measurement_approach":"Pharmacokinetic measurements of study drug through Week 12."}
• {"endpoint_text":"- Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12.","definition_or_measurement_approach":"Immunogenicity: proportion of participants with anti-drug antibodies measured through Week 12."}

Primary sponsor

Full Name

Spyre Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Psi Cro AG

Responsibilities

Sponsor third party with duties codes recorded (1,12,2,5,6) - listed as a third-party in CTIS record

Name

Syneos Health Inc.

Responsibilities

Sponsor third party with duties code recorded (8) - listed as a third-party in CTIS record

Name

Fisher Clinical Services GmbH

Responsibilities

Sponsor third party with duties code recorded (14) - listed as a third-party in CTIS record

Name

Psi CRO Greece

Responsibilities

Sponsor third party with duties codes recorded (1,12,2) - listed as a third-party in CTIS record

Third parties

• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: 4 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"sponsorDuties codes: 1,12,2,5,6 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 8 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4 (as recorded)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"sponsorDuties: 15 (RBM)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"sponsorDuties code: 4 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7 (as recorded)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"sponsorDuties codes: 1,12,2 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties code: 14 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Deltamed Solutions Inc.","duties_or_roles":"sponsorDuties code: 10 (as recorded)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3 (as recorded)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties: 15 (Central Imaging)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC (alternate address)","duties_or_roles":"sponsorDuties code: 4 (as recorded)","organisation_type":"Pharmaceutical company"}