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Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

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ClinicalTrials.gov Identifier: NCT03341962
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Immunic AG

Brief Summary:
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 in moderate-to-severe ulcerative colitis (CALDOSE-1).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: IMU-838 Drug: Placebo Phase 2

Detailed Description:

The investigational medicinal product (IMP) IMU-838 (vidofludimus calcium) is a new compound that selectively inhibits the human enzyme dihydroorotate dehydrogenase (DHODH). Dihydroorotate dehydrogenase plays a major role in the de-novo pyrimidine synthesis and is specifically expressed at high levels in proliferating or activated lymphocytes. Resting lymphocytes satisfy their pyrimidine requirements through a DHODH-independent salvage pathway. Thus, IMU-838-mediated DHODH inhibition selectively affects activated, rapidly proliferating lymphocytes. The metabolic stress secondary to DHODH inhibition leads to a reduction of pro-inflammatory cytokine release including interleukin (IL)-17 (IL-17A and IL-17F) and interferon gamma (IFNγ), and to an increased apoptosis in activated lymphocytes.

This is a phase 2, multicenter, randomized, double-blind, and placebo-controlled trial in patients with moderate-to-severe UC with an option for open-label treatment extension. The study comprises a blinded induction phase to establish the optimal dose of IMU-838 to induce response and remission, a blinded maintenance phase to evaluate the potential of IMU-838 to maintain remission until Week 50, and an open-label treatment extension arm for all patients who discontinue the blinded phase as scheduled or prematurely, subject to certain restrictions. A subset of patients will undergo a pharmacokinetic (PK) period at the start of the open-label period to establish a full single-dose PK profile.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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 in Moderate-to-severe Ulcerative Colitis
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10 mg IMU-838 (Induction)
Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks (Period 1) followed by an additional 10 to 22 weeks (Period 2) depending on the results of an interim analysis.
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Experimental: 30 mg IMU-838 (Induction)
Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks (Period 1) followed by an additional 10 to 22 weeks (Period 2) depending on the results of an interim analysis.
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Experimental: 45 mg IMU-838 (Induction)
Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks (Period 1) followed by an additional 10 to 22 weeks (Period 2) depending on the results of an interim analysis.
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Placebo Comparator: placebo (during induction)
The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging.
Drug: Placebo
Tablets manufactured to mimic IMU-838 tablets
Other Name: Placebo (for IMU-838)

Experimental: 10 mg IMU-838 (Maintenance)
Two 5 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Experimental: 30 mg IMU-838 (Maintenance)
Two 15 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Experimental: 30 mg IMU-838 (Open-label)
Two 5 mg tablets once daily of IMU-838 for up to 10 years
Drug: IMU-838
IMU-838 tablet
Other Names:
  • IM90838
  • vidofludimus calcium

Placebo Comparator: placebo (during maintenance)
The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging. Patients who have received placebo during the induction phase will be 're-randomized' to continue to receive placebo (in a blinded fashion).
Drug: Placebo
Tablets manufactured to mimic IMU-838 tablets
Other Name: Placebo (for IMU-838)




Primary Outcome Measures :
  1. Symptomatic remission and endoscopic healing [ Time Frame: Week 10 ]

    Composite endpoint: Proportion of patients with both, symptomatic remission and endoscopic healing at Week 10.

    All patients (both, Enrollment Period 1 and Enrollment Period 2 patients) who were randomized to the active dose(s) selected for Enrollment Period 2 will be used for the assessment of the primary efficacy endpoint



Secondary Outcome Measures :
  1. Symptomatic remission and endoscopic healing at different doses [ Time Frame: Week 10 ]

    If 2 IMU-838 doses are continued in Enrollment Period 2: proportion of patients with both symptomatic remission and endoscopic healing at Week 10 for the following comparisons:

    • the higher active dose versus placebo
    • the lower active dose versus placebo
    • lower versus the higher active dose

  2. Symptomatic remission during induction [ Time Frame: 22 weeks ]
    Proportion of patients achieving symptomatic remission during the induction phase (including extended induction phase)

  3. Time to achieving symptomatic remission [ Time Frame: 22 weeks ]
    Time to achieving symptomatic remission within the induction/extended induction phase

  4. Proportion of patients with clinical response [ Time Frame: 10 weeks ]
    Proportion of patients with clinical response at Week 10

  5. Proportion of patients with endoscopic healing [ Time Frame: Week 10 ]
    Proportion of patients with endoscopic healing at Week 10

  6. Proportion of patients with symptomatic response [ Time Frame: 22 weeks ]
    Proportion of patients with symptomatic response during the induction phase (including extended induction phase)

  7. Full Mayo Score [ Time Frame: Week 10 ]
    Change in full Mayo Score compared to baseline at Week 10

  8. Partial Mayo Score [ Time Frame: Up to Week 22 ]
    Change in partial mayo score over 10 or 22 weeks

  9. Patient Reported Outcome (PRO)-2 Mayo Score [ Time Frame: Up to Week 22 ]
    Change in PRO-2 mayo score over 10 or 22 weeks

  10. Fecal calprotectin (fCP) [ Time Frame: Changes from Baseline over 10 or 22 weeks ]
    Change in the presence of biomarker fCP in stool samples

  11. C-reactive protein (CRP) [ Time Frame: Changes from Baseline over 10 or 22 weeks ]
    Change in the presence of biomarker CRP in blood samples

  12. Safety: Adverse Events [ Time Frame: up to Week 50 ]
    Incidence and Severity of AEs

  13. Safety: Number of participants with clinically significant findings during physical examination [ Time Frame: up to Week 50 ]
    The emergence of any clinically significant findings compared to screening will be captured during the induction and maintenance phases

  14. Safety: body weight [ Time Frame: up to Week 50 ]
    Changes in body weight during the induction and maintenance phases

  15. Safety: blood pressure [ Time Frame: up to Week 50 ]
    Changes in blood pressure (mm Hg) during the induction and maintenance phases

  16. Safety: heart rate [ Time Frame: up to Week 50 ]
    Changes in heart rate (beats per minute) during the induction and maintenance phases

  17. Safety: 12-lead electrocardiogram (ECG) [ Time Frame: up to Week 50 ]
    Number of patients with clinically significant changes in ECG

  18. Safety: Hematology [ Time Frame: up to Week 50 ]
    Number of participants with abnormal hematology laboratory values

  19. Safety: Blood Chemistry [ Time Frame: up to Week 50 ]
    Number of participants with abnormal blood chemistry laboratory values

  20. Safety: Coagulation [ Time Frame: up to Week 50 ]
    Number of participants with abnormal coagulation laboratory values

  21. Safety: Urinalysis [ Time Frame: up to Week 50 ]
    Number of participants with abnormal urinalysis laboratory values

  22. Safety: Micro ribonucleic acid expression [ Time Frame: pre-dose and 24 hours post-dose ]
    Micro ribonucleic acid-122 (miR-122) expression (before first dose and 24 hours after first dose)

  23. PK: IMU-838 trough level [ Time Frame: up to Week 10 ]
    Measurement of pre-dose (trough) blood plasma levels of IMU-838 throughout the induction period

  24. PK: IMU-838 plasma level [ Time Frame: Week 2 ]
    Measurement of post-dose blood plasma levels of IMU-838 at Week 2

  25. PK: area under the drug concentration-time curve (AUC) from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose ]
    Single-dose PK measurement of AUC0-24h in a subset of patients in the open-label phase

  26. PK: AUC time zero to last measurable concentration (AUC0-t) [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose ]
    Single-dose PK measurement of AUC0-t in a subset of patients in the open-label phase

  27. PK: AUC time zero to infinity (AUC0-inf) [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose ]
    Single-dose PK measurement of AUC0-inf in a subset of patients in the open-label phase

  28. PK: maximum plasma concentration (Cmax) [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose ]
    Single-dose PK measurement of Cmax in a subset of patients in the open-label phase

  29. PK: time to Cmax (Tmax) [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose ]
    Single-dose PK measurement of Tmax in a subset of patients in the open-label phase

  30. Maintenance Phase: Proportion of patients with symptomatic response [ Time Frame: up to Week 50 ]
    Proportion of patients in symptomatic remission by visit up to Week 50

  31. Maintenance Phase: Mayo PRO-2 score [ Time Frame: Week 50 ]
    Time course of Mayo PRO-2 score until Week 50

  32. Maintenance Phase: Time to relapse [ Time Frame: up to Week 50 ]
    Time to symptomatic ulcerative colitis (UC) relapse

  33. Maintenance Phase: Proportion of patients without relapse [ Time Frame: Week 50 ]
    Proportion of patients without symptomatic UC relapse until Week 50

  34. Maintenance Phase: fCP [ Time Frame: up to Week 50 ]
    Change in the presence of biomarker fCP in stool samples

  35. Maintenance Phase: CRP [ Time Frame: up to Week 50 ]
    Change in the presence of biomarker CRP in blood samples

  36. Maintenance Phase: Proportion of patients with endoscopic healing [ Time Frame: Week 50 ]
    Proportion of patients with endoscopic healing at Week 50

  37. Maintenance Phase: Proportion of patients with microscopic healing [ Time Frame: Week 50 ]
    Proportion of patients with microscopic healing at Week 50

  38. Maintenance Phase: corticosteroid-free remission [ Time Frame: Week 50 ]
    Corticosteroid-free remission at Week 50 in patients receiving corticosteroids at Baseline

  39. Open-label Phase: symptom control [ Time Frame: Up to 10 years ]
    Proportion of patients with symptom control

  40. Open-label Phase: fCP [ Time Frame: Up to 10 years ]
    Change in the presence of biomarker fCP in stool samples

  41. Open-label Phase: CRP [ Time Frame: Up to 10 years ]
    Change in the presence of biomarker fCP in blood samples



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Induction phase

  1. Male and female patients, aged 18 - 80 years
  2. UC diagnosed more than 3 months before Screening (Day-30) as documented in the medical chart
  3. Previous treatment failure defined as:

    1. 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
    2. 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.)
  4. Active symptoms defined as a Mayo stool frequency score of ≥2 and a 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)
  5. 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)
  6. 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
  7. Female patients must:

    1. 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
    2. 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.
  8. 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
  9. Ability to understand and comply with study procedures and restrictions
  10. The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions and has duly signed the informed consent form

Maintenance phase

1. Symptomatic remission achieved at Week 10 or Week 22 of the induction phase

Open-label treatment extension arm

1. Patient is in the induction phase, had received at least 6 weeks of blinded study treatment and completed the sigmoidoscopy (incl. biopsy) regularly scheduled at Week 10/End of Induction, and has neither reached symptomatic remission nor symptomatic response

OR

Patient is in the extended induction phase, had completed all Week 10 assessments, and has not reached symptomatic remission during or at the end of the extended induction phase, Or Patient is in the maintenance phase and discontinues from the maintenance phase due to symptomatic UC relapse or other reasons with a flexible sigmoidoscopy performed at discontinuation (if the previous sigmoidoscopy had been performed more than 4 weeks before discontinuation)

OR

Patient has completed the maintenance phase as scheduled (including all Week 50 assessments)

EXCLUSION CRITERIA:

Gastrointestinal exclusion criteria

  1. Diagnosis of Crohn's disease, inflammatory bowel disease type unclassified, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
  2. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  3. History of colectomy with ileorectal anastomosis or ileal-pouch anal anastomosis or imminent need for colectomy (i.e. colectomy is being planned)
  4. Active therapeutically uncontrollable abscess or toxic megacolon
  5. Malabsorption or short bowel syndrome
  6. History of colorectal cancer or colorectal dysplasia (with the exception of dysplasia in polyps which have been removed)

    Infectious disease exclusion criteria

  7. 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
  8. Treatment for intestinal pathogens other than C. difficile within 30 days prior to first randomization
  9. 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
  10. Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine

    Other medical history and concomitant disease exclusion criteria

  11. Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia
  12. Diagnosis or suspected liver function impairment which may cause, as assessed by the investigator, a potential for fluctuating liver function tests during this trial
  13. Renal impairment i.e. calculated creatinine clearance ≤60 mL/min
  14. Serum uric acid levels at Screening >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL)
  15. History or clinical diagnosis of gout
  16. Known or suspected Gilbert syndrome
  17. Indirect (unconjugated) bilirubin ≥1.2 x ULN at Screening (i.e. ≥ 1.1 mg/dL)
  18. Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer

    Therapy exclusion criteria

  19. Use of any investigational product within 8 weeks or 5 x the respective half-life before first randomization, whatever is longer
  20. Use of the following medications within 2 weeks before first randomization:

    1. Tofacitinib
    2. Methotrexate,
    3. Mycophenolate mofetil
    4. Any calcineurin inhibitors (e.g. tacrolimus, cyclosporine, or pimecrolimus)
    5. Oral systemic corticosteroids >20 mg/day prednisolone equivalent including beclomethasone dipropionate (at >5 mg/day) and budesonide (multi-matrix [MMX] at >9 mg/day)
    6. Oral aminosalicylates (e.g. mesalazines) >4 g/day
  21. Use of the following medications within 4 weeks before first randomization:

    1. Use of intravenous corticosteroids
    2. Use of thiopurines including azathioprine, mercaptopurine and 6-thioguanine
    3. Use of any rectal and topical aminosalicylates and/or budesonide
  22. Use of oral systemic corticosteroids ≤20 mg/day prednisolone equivalent including beclomethasone dipropionate (at ≤5 mg/day) and budesonide (MMX at ≤9 mg/day) unless they have been used for at least 4 weeks before first randomization and at a stable dose for at least 2 weeks before first randomization
  23. Oral aminosalicylates (e.g. mesalazines) ≤4 g/day unless they have been used for at least 6 weeks and with a stable dose for at least 3 weeks before first randomization
  24. Use of biologics as follows:

    1. anti-tumor necrosis factor α antibodies (infliximab, adalimumab, golimumab, including their biosimilars) within 4 weeks before first randomization
    2. vedolizumab and ustekinumab within 8 weeks before first randomization
  25. Use of the DHODH inhibitors leflunomide or teriflunomide within 6 months before first randomization
  26. Any use of natalizumab (Tysabri™) within 12 months before first randomization
  27. Use of the following concomitant medications is prohibited at Screening and throughout the duration of the trial:

    • any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid
    • treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafenib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib
    • any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs

    General exclusion criteria

  28. History of, or current serious, severe, or unstable (acute or progressive) physical or mental illness, or any medical condition, including laboratory anomalies or renal or hepatic impairment, that may require treatment or would put the patient in jeopardy if he/she was to participate in the study
  29. Known hypersensitivity to DHODH inhibitors (teriflunomide, leflunomide) or any ingredient of the investigational product
  30. Pregnancy or breastfeeding
  31. History of drug or alcohol abuse during the past year
  32. Concurrent participation in any other clinical trial using an investigational medicinal product or medical device
  33. An employee of an investigator or sponsor or an immediate relative of an investigator

Exclusion criteria for open-label treatment extension arm

  1. Any ongoing, clinically significant (as assessed by the investigator) treatment-emergent (started during the IMU-838 treatment in the blinded treatment arms) adverse event (AE) or laboratory abnormality (including blood chemistry and urinalysis) *
  2. Significant treatment or study non-compliance during induction and/or maintenance phase (as assessed by the investigator), and/or inability or unwillingness to follow instructions by study personnel
  3. Significant protocol deviations during induction and/or maintenance phase that are assessed by the investigator to negatively affect further patient cooperation in this study

    • If treatment-emergent AEs are the reason for exclusion from the open-label extension arm, the eligibility can be re-assessed up to 30 days following the last treatment in the blinded treatment arms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341962


Contacts
Contact: Andreas Muehler +49.89.2500 794 64 andreas.muehler@immunic.de
Contact: Geert D'Haens +31 20 56 63534

Locations
United States, California
Ventura Clinical Trials Recruiting
Ventura, California, United States, 93003
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Sabine Hazan    805-200-7436    sabinehazan@aim.com   
Principal Investigator: Sabine Hazan, Dr.         
United States, Florida
Eastern Research, Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Raquel Gonzalez    305-681-3111    raquel.gonzalez@easternresearchtrials.com   
Principal Investigator: Wilfrido Benitez, Dr.         
Clinical Research Trials of Florida, Inc. Recruiting
Tampa, Florida, United States, 33607
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Ricardo Alpizar    813-873-8102    ralpizar@crtfi.com   
Principal Investigator: Sady Alpizar, Dr.         
United States, Massachusetts
Commonwealth Clinical Studies Recruiting
Brockton, Massachusetts, United States, 02302
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Estelle Crowley    508-588-4511    ecrowley@gisdoc.com   
Principal Investigator: Mark Finklestein, Dr         
United States, North Carolina
PMG Research of Salisbury, LLC Recruiting
Salisbury, North Carolina, United States, 28144
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Michael Britschge    704-647-9913    mbritschge@pmg-research.com   
Principal Investigator: Vlneet Korrapati, Dr.         
United States, South Carolina
Clinical Trials of South Carolina Recruiting
Charleston, South Carolina, United States, 29406
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Taliah Sims    843-789-3707    tsims@clinicaltrialssc.com   
Principal Investigator: Koro Nabeel, Dr.         
United States, Texas
Hermann Drive Surgical Hospital Recruiting
Houston, Texas, United States, 77004
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Harold Minkowitz    713-480-3028    harold@minkowitzmd.com   
Principal Investigator: Jognesh Shah, Dr.         
United States, Washington
Digestive Health Specialists Recruiting
Tacoma, Washington, United States, 98405
Contact: Ryan Granzella    816-807-9604    Ryan.Granzella@Chiltern.com   
Contact: Julie Coard    253-503-2514    jcoard@washgi.com   
Principal Investigator: William Holderman, Dr.         
Sponsors and Collaborators
Immunic AG
Investigators
Study Director: Andreas Muehler Immunic Therapeutics

Additional Information:
Responsible Party: Immunic AG
ClinicalTrials.gov Identifier: NCT03341962     History of Changes
Other Study ID Numbers: P2-IMU-838-UC
P2-IMU-838-UC ( Other Identifier: Sponsor protocol ID )
2017-003703-22 ( EudraCT Number )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunic AG:
Ulcerative Colitis
IMU-838
vidofludimus calcium

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases