2024-520201-39-00
Not yet recruiting
Phase 2
A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis
Odyssey Therapeutics Inc.21 sites in 7 countries47 target enrollmentStarted: June 25, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Odyssey Therapeutics Inc.
- Enrollment
- 47
- Locations
- 21
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs
Overview
Brief Summary
To evaluate the safety and tolerability of OD-07656 in participants with moderately to severely active UC; To evaluate the efficacy of OD-07656 in participants with moderately to severely active UC
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults between 18 (or the minimum age of consent, if different locally) and 75 years of age, at the time of the Screening Visit
- •A diagnosis of UC extending ≥15 cm from the anal verge, established at least 90 days prior to the Screening Visit by clinical and endoscopic evidence of UC (colonoscopy or flexible sigmoidoscopy) and confirmed by histology
- •Moderately to severely active UC, defined as a 3 component MMCS of 5 to 9 points, with RBS ≥1 and MES ≥2 scored centrally
- •A participant must have a colonoscopy or a flexible sigmoidoscopy during the Screening Period. Participants may receive a flexible sigmoidoscopy unless a participant has had extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration. For these participants, a colonoscopy will be required if their last colonoscopy was more than 1 year before the Screening Visit. If the last colonoscopy was less than 1 year before the Screening Visit, then the participant may receive a flexible sigmoidoscopy
- •Demonstrated, in the opinion of the Investigator, an inadequate response, loss of response, or intolerance/medical contraindication to at least 1 of the following treatments as defined in the table below: oral aminosalicylates, corticosteroids, immunosuppressants (i.e., conventional therapies) or biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) modulators (i.e., ATs).
- •Participants who are a person of childbearing potential (POCBP) must have a negative serum pregnancy test at the Screening Visit and a negative urine/serum pregnancy test at Day 1 prior to receiving study intervention. Participants unable to bear children must have documentation of such in the source records. Refer to the full protocol for definitions and specific requirements related to contraception and pregnancy prevention.
- •Capable of providing signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including electronic data capture methods.
Exclusion Criteria
- •Presence of the following: • Acute severe UC, defined by ≥6 bloody diarrhea/day and any signs of systemic toxicity (pulse >90 beats/min, temperature >37.8 °C, hemoglobin <105 g/L, erythrocyte sedimentation rate >30 mm/h, or C-reactive protein [CRP] >30 mg/L); or in the Investigator’s opinion, hospitalization for the treatment of UC may be imminent. • Previous extensive colonic resection (subtotal or total colectomy). • Short bowel syndrome. • Ileostomy, colostomy, ileoanal pouch, fistulae, or known fixed symptomatic stenosis of the intestine. • Toxic megacolon.
- •Hypersensitivity or allergy to OD 07656, or any of its excipients
- •Received any of the following: •Cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 56 days prior to Day
- •IV corticosteroids within 14 days prior to Day
- •Any biologic therapy (e.g., anti-tumor necrosis factors, anti-integrins, anti-interleukins) within 56 days or 5 half lives (whichever is greater) or within 28 days for participants without detectable drug levels prior to Day
- •JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) within 28 days prior to Day
- •S1P modulators (i.e., ozanimod or etrasimod) within 28 days prior to Day
- •IV antibiotics within 56 days prior to Day 1 or expected to receive IV antibiotics during the study. • NSAIDs as long-term treatment, defined as use for at least 4 days a week consistently each week over a period of at least a month (or acetaminophen >1000 mg daily and aspirin >325 mg daily). • Vaccination with a live or live-attenuated vaccine within 28 days prior to Day 1 or during the study. NOTE: It is recommended that participants be up to date for recommended inactivated, toxoid, or biosynthetic vaccines, such as injectable, coronavirus disease of 2019 (COVID 19), influenza, pneumococcal, and pertussis vaccine. • Fecal microbiota transplant (includes human microbiota-based therapeutics) within 28 days prior to Day
- •Oral or injectable anticoagulants including but not limited to warfarin, heparin or heparinoids (i.e., enoxaparin), or direct acting anticoagulants such as Factor Xa inhibitors (i.e., apixaban, fondaparinux, and rivaroxaban) within 14 days prior to Day
- •Oral corticosteroids: any doses >20 mg/day prednisone within the last 28 days, or for doses ≤20 mg/day prednisone, has not been on a stable dose for ≥28 days prior to Day
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs
Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs
Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs
Change from baseline in 3-component modified Mayo Clinic Score (MMCS) (defined as sum of stool frequency subscore [SFS], rectal bleeding subscore [RBS], and Mayo endoscopic subscores [MES]a) at Week X
Change from baseline in 3-component modified Mayo Clinic Score (MMCS) (defined as sum of stool frequency subscore [SFS], rectal bleeding subscore [RBS], and Mayo endoscopic subscores [MES]a) at Week X
Secondary Outcomes
- Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X
- Proportion of participants who have a clinical response per 3 component MMCS (defined as a decrease from baseline of ≥2 points and ≥30%, and either a decrease in RBS of ≥1 point or an absolute RBS of 0 or 1) at Week X
- Proportion of participants who achieve clinical remission per MMCS at Week X
- Proportion of participants who have a clinical response per MMCS at Week X
Investigators
Clinical Operations Development
Scientific
Odyssey Therapeutics Inc.
Study Sites (21)
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