Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).

Key facts

Study ID

NCT03341962

Run by

Immunic AG

People needed

263

Starts

2018-03-15

Expected to finish

2022-11-16

Last updated by the study team

2024-03-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Induction phase
• Male and female patients, aged 18 - 80 years
• UC diagnosed more than 3 months before Screening (Day-30) as documented in the medical chart
• Previous treatment failure defined as:
• Patient had an inadequate response with, lost response to, or was intolerant to approved or experimental immunomodulators (azathioprine, 6-mercaptopurine, 6-thioguanine, methotrexate, or tofacitinib) or biologics (no more than 2 treatment failures with biologic drugs i.e. anti-tumor necrosis factor α antibodies [infliximab, adalimumab, golimumab and their biosimilars], vedolizumab, or certain experimental antibodies [ustekinumab]); or
• Patient had an inadequate response to, was intolerant to, or is corticosteroid dependent (corticosteroid-dependent patients are defined as i) unable to reduce steroids below the equivalent of prednisolone 10 mg/day within 3 months of starting steroids, without recurrent active disease, or ii) who have a relapse within 3 months of stopping steroids.)
• Active disease defined as
• a. Mayo stool frequency score of ≥2 at Screening Visit 1 b. Mayo rectal bleeding score of ≥1 at Screening Visit 1 c. modified Mayo endoscopy subscore of ≥2 at the screening flexible sigmoidoscopy (endoscopy assessed by an independent central reader blinded to screening center and patient information)
• Endoscopic appearance typical for UC and extending >15 cm from the anal verge as confirmed by an independent central reader (blinded to screening center and patient information)
• Laboratory values: Neutrophil count >1500 cells/µL, platelet count ≥100 000 /mm3, serum creatinine <1.5 x upper limit of normal (ULN), total bilirubin, alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) <1.5 x ULN
• Female patients must:
• a. Be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening) or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
• b. If of child-bearing potential, must have a negative pregnancy test at Screening (blood test) and before the first study drug administration (Day 0 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method 2 months before Screening, during treatment with IMU-838, and at least 3 months after the last dose of study therapy
• Highly effective forms of birth control are those with a failure rate less than 1% per year and include:
• oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation
• oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation
• intrauterine device or intrauterine hormone-releasing system
• bilateral tubal occlusion
• vasectomized partner (i.e. the patient's male partner has undergone effective surgical sterilization before the female patient entered the clinical trial and he is the sole sexual partner of the female patient during the clinical trial)
• sexual abstinence (acceptable only if it is the patient's usual form of birth control/lifestyle choice) 8. Male patients must agree not to father a child or to donate sperm starting at Screening and throughout the clinical trial and for 3 months after the last dose of study medication.
• Male patients must also either
• abstain from sexual intercourse with a female partner (acceptable only if it is the patient's usual form of birth control/lifestyle choice), or
• use adequate barrier contraception during treatment with IMU-383 and for at least 3 months after the last dose of study medication
• For Poland and the UK the following additional requirement apply:
• if male patients have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 7

You may not qualify if…

• Gastrointestinal exclusion criteria
• Diagnosis of Crohn's disease, inflammatory bowel disease type unclassified, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
• History of colectomy with ileorectal anastomosis or ileal-pouch anal anastomosis or imminent need for colectomy (i.e. colectomy is being planned)
• Active therapeutically uncontrollable abscess or toxic megacolon
• Malabsorption or short bowel syndrome
• History of colorectal cancer or colorectal dysplasia (with the exception of dysplasia in polyps which have been removed)
• Infectious disease exclusion criteria
• Clostridium difficile (C. difficile) infection
• Evidence of, or treatment for C. difficile infection within 30 days before first randomization
• Positive C. difficile toxin B stool assay during the screening period
• Treatment for intestinal pathogens other than C. difficile within 30 days prior to first randomization
• Other chronic systemic infections
• History of chronic systemic infections including but not limited to tuberculosis, human immunodeficiency virus (HIV), hepatitis B or C, within 6 months before Screening
• Positive interferon-gamma release assay (IGRAs) for Mycobacterium tuberculosis at Screening
• Positive HBsAg (hepatitis B virus surface antigen), HBcAb (hepatitis B core antibody), positive hepatitis C virus and/or HIV-antigen-antibody (HIV-Ag/Ab) test at Screening
• Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine
• Other medical history and concomitant disease exclusion criteria
• Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia
• Diagnosis or suspected liver function impairment which may cause, as assessed by the investigator, a potential for fluctuating liver function tests during this trial
• Renal impairment i.e. estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m²
• Serum uric acid levels at Screening >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL)
• History or clinical diagnosis of gout
• Known or suspected Gilbert syndrome
• Indirect (unconjugated) bilirubin ≥1.2 x ULN at Screening (i.e. ≥ 1.1 mg/dL)

Where it is running

• Axis Clinical Trials — Los Angeles, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Alliance Medical Research, LLC — Lighthouse PT, Florida, United States
• Medley Research Associates — Medley, Florida, United States
• Global Life Research LLC — Miami, Florida, United States
• Family Clinical Trials — Pembroke Pines, Florida, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States
• McFarland Clinic, P.C. — Ames, Iowa, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• PMG Research of Salisbury, LLC — Salisbury, North Carolina, United States
• Clinical Trials of South Carolina — Charleston, South Carolina, United States
• First Street Surgical Hospital — Bellaire, Texas, United States
• Digestive Health Specialists — Tacoma, Washington, United States
• Durres Regional Hospital — Durrës, Albania
• Regional Hospital of Shkoder — Shkoder, Albania
• University Hospital Center Mother Teresa — Tirana, Albania
• Gomel Regional Clinical Hospital — Homyel, Belarus
• Republican Scientific and Practical Center for Radiation Medicine and Human Ecology — Homyel, Belarus
• Vitiebsk State Order of Peoples' Friendship Medical University — Vitebsk, Belarus
• University Clinical Centre of the Republic of Srpska, Internal Medicine Clinic, Department of Gastroenterology and Hepatology — Banja Luka, Bosnia and Herzegovina
• University Clinical Hospital Mostar, Internal Medicine Clinic, Department of Gastroenterology — Mostar, Bosnia and Herzegovina
• Multiprofile Hospital for Active Treatment Blagoevgrad AD — Blagoevgrad, Bulgaria
• Mhat Byala — Byala, Bulgaria
• Del Sol Research Management, LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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