Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: SPY001-001: (150mg/ml) Intravenous administration approximately 48 weeks
Intervention2: SPY001-001: (180mg/ml) Subcutaneous administration
approximately 48 weeks
Intervention3: SPY00
Sponsors
Spyre Therapeutics, Inc.
PSI CRO PHARMA India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult participants must have had a diagnosis of UC for greater than or equal to 3 months before Day 1 confirmed by endoscopy and histology either previously or during Screening. If documentation of confirmatory endoscopy or histology is not available for review, additional biopsies during screening endoscopy may be performed and sent to a local histology laboratory for histologic assessment documenting findings consistent with UC. On histology, any mention of UC, chronic inflammation, or equivalent is considered adequate. 2. Active UC with disease extent of greater than or equal to 15 cm from the anal verge, as confirmed by Screening endoscopy, with the exception of up to approximately 15 percentage of the total population permitted to have only proctitis (less than15 cm from the anal verge). 3. Moderately to severely active disease as defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of greater than or equal to 1, and Mayo endoscopic subscore greater than or equal to 2. 4. History of corticosteroid dependence, OR inadequate response,1 OR loss of response, 2 OR intolerance to 1 of the following: a. conventional therapy only (oral locally acting or systemic corticosteroids, or immunosuppressants) (target of approximately 40 percentage â?? 60 percentage of the planned sample size) OR b. approved advanced therapies, ie anti-TNF, anti-alpha4beta7, anti-IL-12 or IL-23, anti-IL-23, JAK inhibitors, or S1P receptor antagonists), as defined in the full protocol (target of approximately 40 percentage to 60 percentage of the planned sample size). 5. Participants taking oral corticosteroids (up to 20 mg per day prednisone or equivalent, 9 mg per day budesonide, or 5 mg per day beclomethasone) must be on a stable dose for greater than or equal to 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
Exclusion criteria: 1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-alpha4beta7, anti-IL-12 or IL-23, anti-IL-23, JAK inhibitors, and S1P receptor antagonists) at the approved labeled dose or higher, if applicable. 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: â?? anti-alpha4beta7 (eg, vedolizumab), â?? anti-TL1A, or â?? anti-IL-23 (eg, mirikizumab, guselkumab, risankizumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A: To assess the effects of intervention on histologic disease activity following 12 weeks of treatment PART B: To assess the efficacy of intervention in inducing clinical remission following 12 weeks of treatmentTimepoint: PART A: Change in RHI from baseline at Week 12 PART B: Clinical remission at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| PART A: To assess the efficacy of intervention in inducing clinical remission following 12 weeks of treatmentTimepoint: Clinical remission at Week 12;PART A: To assess the efficacy of intervention in inducing endoscopic improvement following 12 weeks of treatmentTimepoint: Endoscopic improvement at Week 12;PART B: To assess the efficacy of intervention in inducing endoscopic improvement following 12 weeks of treatmentTimepoint: Endoscopic improvement at Week 12;PART B: To assess the efficacy of intervention in inducing clinical response following 12 weeks of treatmentTimepoint: Clinical response at Week 12;PART B: To assess the efficacy of intervention in inducing histologic improvement following 12 weeks of treatmentTimepoint: Histologic improvement at Week 12;PART B: To assess the efficacy of intervention in inducing HEMI following 12 weeks of treatmentTimepoint: HEMI at Week 12;PART B: To assess the efficacy of intervention in achieving clinical remission at the end of MTPTimepoint: Clinical remission at Week 48 | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Kazakhstan, Lithuania, Mexico, Poland, Republic of Korea, Republic of Moldova, Romania, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Radhika Bobba
PSI CRO PHARMA India Private Limited
Outcome results
None listed