OD-07656 HYDROCHLORIDE for Ulcerative colitis|Moderately to severely active ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Adults between 18 (or the minimum age of consent, if different locally) and 75 years of age, at the time of the Screening Visit\n- 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\n- Moderately to severely active UC, defined as a 3 component MMCS of 5 to 9 points, with RBS ≥1 and MES ≥2 scored centrally\n- 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\n- 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).\n- 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.\n- 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

• {"criterion_text":"- Presence of the following: •\tAcute 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. •\tPrevious extensive colonic resection (subtotal or total colectomy). •\tShort bowel syndrome. •\tIleostomy, colostomy, ileoanal pouch, fistulae, or known fixed symptomatic stenosis of the intestine. •\tToxic megacolon.\n- Hypersensitivity or allergy to OD 07656, or any of its excipients\n- Received any of the following: •Cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 56 days prior to Day 1. •\tIV corticosteroids within 14 days prior to Day 1. •\tAny 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 1. •\tJAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) within 28 days prior to Day 1. •\tS1P modulators (i.e., ozanimod or etrasimod) within 28 days prior to Day 1. •\tIV antibiotics within 56 days prior to Day 1 or expected to receive IV antibiotics during the study. •\tNSAIDs 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). •\tVaccination 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. •\tFecal microbiota transplant (includes human microbiota-based therapeutics) within 28 days prior to Day 1. •\tOral 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 1. •\tOral 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 1. •\tOral budesonide dose >9 mg/day within the last 28 days, or for doses ≤9 mg/day, has not been on a stable dose for ≥28 days prior to Day 1. •\tOral 5-aminosalicylic acid drugs or sulfasalazine: any doses >4.8 g/day within the last 28 days or for doses ≤4.8 g/day, has not been on a stable dose for ≥28 days prior to Day 1. •\tPurine analogues (e.g., AZA, 6-MP, thioguanine) or MTX have been discontinued within 28 days prior to Day 1.\n- Laboratory results that meet the following limits: Parameter\tExclusion AST or ALT\t>2 × ULN eGFR\t<30 mL/min/1.73 m2 (by MDRD or by Schwartz a) WBC\t<2500/μL (<2.5 GI/L) ANC\t<1200/μL (<1.2 GI/L) Platelet count\t<100,000/μL (<100 GI/L) Absolute lymphocyte count\t<750/μL (<0.75 GI/L) Hemoglobin\t<9 g/dL (<90 g/L) Abbreviations: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; MDRD, Modification of Diet in Renal Disease; ULN, upper limit of normal; WBC, white blood cell. a\teGFR will be calculated using the MDRD equation for participants ≥18 years old. The Schwartz equation will be used for participants <18 years old.\n- Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Day 1\n- Any major surgery, in the Investigator’s opinion, performed within 8 weeks prior to Day 1 or planned during the study (i.e., any surgical procedure requiring general anesthesia).\n- Currently breastfeeding or planning to breastfeed during the study\n- History of excessive alcohol consumption or drug abuse that in the opinion of the Investigator may interfere with the participant’s ability to comply with the study procedures.\n- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, investigational product administration, or may interfere with the interpretation of study results, as determined by the Investigator\n- Prior enrollment in the current study and had received treatment with OD 07656.\n- Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling).\n- Current diagnosis of Crohn’s disease, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption\n- Is performing mandatory military service, deprived of liberty, in a residential care institution, or due to a judicial decision cannot take part in a clinical study\n- Participants with disease limited to the rectum (ulcerative proctitis) at the Screening Visit\n- Uncontrolled primary sclerosing cholangitis\n- Malignancies or history of malignancy within 5 years of the Screening Visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ\n- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly\n- Systemic or opportunistic infections (detailed criteria in protocol)"}

Primary endpoints

• {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs","definition_or_measurement_approach":"Safety will be assessed by recording incidence of TEAEs, serious TEAEs, TEAEs of special interest and discontinuations due to TEAEs as reported during treatment and follow-up (as per protocol safety reporting procedures)."}
• {"endpoint_text":"- Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs","definition_or_measurement_approach":"Laboratory tests, ECGs and vital signs measured at scheduled visits; change from baseline will be summarised per protocol clinical laboratory and ECG assessment procedures."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Efficacy measured as change from baseline in the 3-component MMCS (SFS+RBS+MES) at the prespecified Week X; MES and RBS scored centrally as defined in protocol."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X","definition_or_measurement_approach":"Binary endpoint based on MMCS components at Week X; remission defined as MMCS ≤2 with component thresholds SFS ≤1, RBS = 0, MES ≤1."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Clinical response defined as ≥2 point and ≥30% decrease from baseline in MMCS and specified RBS improvement; assessed at Week X."}
• {"endpoint_text":"- Proportion of participants who achieve clinical remission per MMCS at Week X","definition_or_measurement_approach":"Proportion meeting MMCS-defined remission at Week X (per MMCS criteria in protocol)."}

Methods

• Participant Recruitment Letter (country-specific participant recruitment letters listed in documents; e.g., BE (nl,de,fr), HR, PL, LT)
• Welcome booklet / K2 Recruitment material (country-specific welcome booklet documents: BE, HR, HU, PL, LT, CZ, AT)
• Patient brochure and posters (country-specific K2 recruitment materials and posters listed)
• Site-based recruitment using provided recruitment arrangements documents (K1 documents per country)

Austria

Earliest CTIS Part Ii Submission Date

06-05-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

55

Number Of Sites

1

Number Of Participants

3

Belgium

Earliest CTIS Part Ii Submission Date

26-05-2025

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

30

Number Of Sites

1

Number Of Participants

3

Croatia

Earliest CTIS Part Ii Submission Date

13-06-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

17

Number Of Sites

4

Number Of Participants

4

Czechia

Earliest CTIS Part Ii Submission Date

19-05-2025

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

38

Number Of Sites

1

Number Of Participants

3

Hungary

Earliest CTIS Part Ii Submission Date

02-05-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

59

Number Of Sites

2

Number Of Participants

4

Lithuania

Earliest CTIS Part Ii Submission Date

29-05-2025

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

28

Number Of Sites

1

Number Of Participants

3

Poland

Earliest CTIS Part Ii Submission Date

28-05-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

33

Number Of Sites

8

Number Of Participants

50

Primary sponsor

Full Name

Odyssey Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Suvoda LLC

Responsibilities

code: 3

Third parties

• {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"Medical & laboratory equipment rental","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"codes: 1,12,2,8 (as listed)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Banook Central Imaging","duties_or_roles":"Central ECG reading, processing ECG","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Regulatory Pharma Net S.r.l.","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs, LLC","duties_or_roles":"code: 4","organisation_type":"Health care"}
• {"country":"Puerto Rico","full_name":"TransPerfect International LLC","duties_or_roles":"Translation Service","organisation_type":"Health care"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Verasafe LLC","duties_or_roles":"Data Privacy","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"HC Research, LLC (Harbor Clinical)","duties_or_roles":"Pharmacovigilance; code: 8","organisation_type":"Health care"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimburesement","organisation_type":"Non-Pharmaceutical company"}