临床试验/2024-520201-39-00

2024-520201-39-00招募中2 期

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 个研究点分布在 7 个国家目标入组 47 人开始时间: 2025年6月25日最近更新: 2025年6月30日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 47
试验地点: 21
主要终点: Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 是

入选标准

•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.

排除标准

•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
•Oral 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
•Oral 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
•Purine analogues (e.g., AZA, 6-MP, thioguanine) or MTX have been discontinued within 28 days prior to Day
•Laboratory results that meet the following limits: Parameter Exclusion AST or ALT >2 × ULN eGFR <30 mL/min/1.73 m2 (by MDRD or by Schwartz a) WBC <2500/μL (<2.5 GI/L) ANC <1200/μL (<1.2 GI/L) Platelet count <100,000/μL (<100 GI/L) Absolute lymphocyte count <750/μL (<0.75 GI/L) Hemoglobin <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 eGFR will be calculated using the MDRD equation for participants ≥18 years old. The Schwartz equation will be used for participants <18 years old.
•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
•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).
•Currently breastfeeding or planning to breastfeed during the study
•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.
•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
•Prior enrollment in the current study and had received treatment with OD
•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).
•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
•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
•Participants with disease limited to the rectum (ulcerative proctitis) at the Screening Visit
•Uncontrolled primary sclerosing cholangitis
•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
•History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
•Systemic or opportunistic infections: • A positive diagnostic tuberculosis (TB) test (defined as a positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once and if their second test is negative, they will be eligible. In the event a second test is also indeterminate, or QuantiFERON is unavailable, the Investigator has the option to perform a purified protein derivative (PPD) skin test. If the PPD reaction is <5 mm, then the participant is eligible. If the reaction is ≥5 mm, or PPD testing is not done, the participant is not eligible. An exception is made for participants with a history of latent TB who have documentation of completing ≥6 months of locally approved treatment for latent TB within 10 years prior to the first dose of study intervention. NOTE: Chest X-Ray during the Screening Period, read by a qualified radiologist, must be negative for findings suggestive of active TB (e.g., pulmonary infiltration, hilar adenopathy, granuloma(s), or pleural thickening). • A positive test for hepatitis B virus (HBV), as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test. NOTE: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no HBV deoxyribonucleic acid (DNA) is present, confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed by the central laboratory. • A positive test for hepatitis C virus (HCV), as defined by a positive HCV antibody (Ab) test and detectable HCV ribonucleic acid (RNA). NOTE: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks prior to Day 1]). • A positive test for serum human immunodeficiency virus (HIV) as defined by a positive serum HIV Ab test. • Evidence of Clostridioides difficile toxin, Escherichia coli (pathogenic), Salmonella, Shigella, Campylobacter, or Yersinia species or treatment for C. difficile infection, listeriosis, or other intestinal bacterial or parasitic pathogen, within 4 weeks prior to the Screening Visit, or a positive test for any of the above pathogens performed at screening. NOTE: Participants will be allowed to qualify at least 4 weeks after completion of antimicrobial treatment and have documentation of negative tests on 2 consecutive stool samples at least 3 days apart. • Has or ever has had any serious opportunistic infection (e.g., cytomegaloviral colitis, Pneumocystis carinii, aspergillosis, histoplasmosis). • Any other clinically significant extra-intestinal infection or opportunistic, chronic, or recurring infection within 6 months prior to Day 1, including, but not limited to infections requiring IV antibiotics (e.g., sepsis), hospitalization, or prolonged anti-infective treatment.
•History of any major neurologic disorder or progressive multifocal leukoencephalopathy (PML), or signs/symptoms of any active cerebral/meningeal disease at the Screening Visit.
•Hypersensitivity or allergy to vedolizumab or any other contraindication to vedolizumab, or any of its excipients

结局指标

主要结局

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

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

次要结局

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

研究者

发起方

Odyssey Therapeutics Inc.

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Clinical Operations Development

Scientific

Odyssey Therapeutics Inc.

研究点 (21)

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