Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

NCT ID: NCT03341962

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2022-11-16

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 with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

10 mg IMU-838 (Induction)

Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22.

Patients will receive only half of their assigned full dose during the first week of treatment.

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

30 mg IMU-838 (Induction)

Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22.

Patients will receive only half of their assigned full dose during the first week of treatment.

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

45 mg IMU-838 (Induction)

Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22.

Patients will receive only half of their assigned full dose during the first week of treatment.

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

placebo (Induction)

The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets manufactured to mimic IMU-838 tablets

10 mg IMU-838 (Maintenance)

Two 5 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

30 mg IMU-838 (Maintenance)

Two 15 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

placebo (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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets manufactured to mimic IMU-838 tablets

30 mg IMU-838 (Open-label)

Two 15 mg tablets once daily of IMU-838 or one 30 mg tablet IMU-838 once daily for up to 10 years and up to 3 years in UK sites

Group Type: EXPERIMENTAL

IMU-838

Intervention Type: DRUG

IMU-838 tablet

Interventions

IMU-838

IMU-838 tablet

Intervention Type: DRUG

Placebo

Tablets manufactured to mimic IMU-838 tablets

Intervention Type: DRUG

Other Intervention Names

IM90838; vidofludimus calcium; Placebo (for IMU-838)

Eligibility 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 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)

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:

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.

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

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

And additionally, for Poland only:

• if male patients have a pregnant partner, they must use condoms while taking study medication to avoid exposure of the fetus to 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

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)

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

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. estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m²

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

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
• Rosuvastatin at doses ˃10 mg/day

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

1. Any ongoing, clinically significant treatment-emergent (started during the IMU-838 treatment in the blinded treatment arms) adverse event (AE) or laboratory abnormality (including blood chemistry and urinalysis) as assessed by the investigator *

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 as assessed by the investigator

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunic AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Muehler

Role: STUDY_DIRECTOR

Immunic Therapeutics

Locations

Všeobecná fakultní nemocnice v Praze IV. interní klinika VFN a 1. LF UK

Prague, , Czechia

Del Sol Research Management, LLC

Tucson, Arizona, United States

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

Shkodër, , 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

Multiprofile Hospital for Active Treatment "Dr. Hristo Stambolski" EOOD

Kazanlak, , Bulgaria

Medical Center "Medconsult Pleven" OOD

Pleven, , Bulgaria

Medical Center Exacta Medica

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Gastroenterology clinic

Plovdiv, , Bulgaria

Medical Center "Hera" EOOD

Sofia, , Bulgaria

Diagnostic-Consulting Center "Convex" EOOD

Sofia, , Bulgaria

General Hospital Bjelovar

Bjelovar, , Croatia

Clinical Hospital Center Osijek

Osijek, , Croatia

Clinical Hospital Center Rijeka

Rijeka, , Croatia

Clinical Hospital Center Split

Split, , Croatia

General Hospital Vukovar

Vukovar, , Croatia

Clinical Hospital Center Zagreb

Zagreb, , Croatia

Clinical Hospital Dubrava

Zagreb, , Croatia

Polyclinic Solmed Zagreb

Zagreb, , Croatia

Clinical Hospital Center Split

Zagreb, , Croatia

Asclepiades - Interna a gastroenterologie s.r.o. - Havířov

Havířov, , Czechia

Hepato-Gastroenterologie HK, s.r.o. Poliklinika III

Hradec Králové, , Czechia

Artroscan s.r.o.

Ostrava - Třebovice, , Czechia

FaraCol s.r.o. - Prague

Prague, , Czechia

MEDICON a.s. - Poliklinika Budějovická Gastroenterologie

Prague, , Czechia

Klinika ResTrial

Prague, , Czechia

Academician Z.Tskhakaia West Georgia National Center of Interventional Medicine

Kutaisi, , Georgia

LTD Unimedi Kakheti - Caraps Medline

Tbilisi, , Georgia

Amsterdam UMC, locatie AMC

Amsterdam, , Netherlands

Albert Schweitzer Hospital

Dordrecht, , Netherlands

Elisabeth-TweeSteden Hospital

Tilburg, , Netherlands

City General Hospita 8th September

Skopje, , North Macedonia

University Clinic for Hematology - Skopje - Macedonian Hematology Association

Skopje, , North Macedonia

Centrum Usług Medycznych MaxMed

Bochnia, , Poland

Centrum Medyczne Pratia Gdynia

Gdynia, , Poland

Centrum Medyczne Endo-med Sp. z o.o.

Karczew, , Poland

Vita Longa Sp. z o.o.

Katowice, , Poland

GLOBE Badania Kliniczne Sp. z o.o.

Kłodzko, , Poland

Salve Medica Sp. z o.o. Spółka Komandytowa

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddział Gastroenterologii

Lublin, , Poland

Zakład leczniczy ALLMEDICA BADANIA KLINICZNE Sp. z o.o. Sp. K.

Nowy Targ, , Poland

Etyka Ośrodek Badań Klinicznych

Olsztyn, , Poland

Ars Medical - Szpital, Ars Medical - Ambulatorium

Piła, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

Niepubliczny Zakład Opieki Zdrowotnej Centrum Medyczne HCP - Lecznictwo Stacjonarne

Poznan, , Poland

Endoskopia Sp. z o.o.

Sopot, , Poland

Klinika Medifem

Warsaw, , Poland

Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski dr Anna Bochenek-Mularczyk

Warsaw, , Poland

Przychodnia Vistamed

Wroclaw, , Poland

Centrum Medyczne OMNI Clinic Sp. z o.o. Spółka Komandytowa

Wroclaw, , Poland

Centrum Medyczne Med-Gastr Sp. z o.o. Spółka Komandytowa

Łódz, , Poland

Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Hospital da Senhora da Oliveira - Guimarães, EPE

Guimarães, , Portugal

Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital São Sebastião

Santa Maria da Feira, , Portugal

S.C. MEDLIFE S.A., Sectia Gastroenterologie

Bucharest, , Romania

Spitalul Clinic Colentina, Sectia Gastroenterologie

Bucharest, , Romania

Institutul Clinic Fundeni, Sectia Clinica Gastroenterologie III

Bucharest, , Romania

S.C. Cabinet Particular Policlinic Algomed SRL, Specialitatea Gastroenterologie

Timișoara, , Romania

Kazan State Medical University

Kazan', , Russia

SEI HPE "Kuban State Medical University" of MoH and SD, CBHS Regional Clinical Hospital No.2

Krasnodar, , Russia

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, , Russia

Federal Medical Biophysical Center n.a. Burnazyan

Moscow, , Russia

Clinical Research Institution of Moscow Region named after M. F. Vladimirsky

Moscow, , Russia

Novosibirskiy Gastrocenter, LLC

Novosibirsk, , Russia

FSBEI HE "Military Medical Academy n.a. S.M. Kirov" under the Ministry of Defence of Russian Federation

Saint Petersburg, , Russia

Hospital of Saint Martyr Elizaveta

Saint Petersburg, , Russia

Research Center Eco-Safety, LLC

Saint Petersburg, , Russia

Gastroenterological Center "Expert" LLC

Saint Petersburg, , Russia

Saint Petersburg State Medical University named after I.P. Pavlov

Saint Petersburg, , Russia

City Hospital No. 5 - Sochi

Sochi, , Russia

Siberian State Medical University

Tomsk, , Russia

Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"

Tomsk, , Russia

Clinic for gastroenterohepatology

Belgrade, , Serbia

Clinical Hospital Center Zemun

Belgrade, , Serbia

University Hospital Center Bezaniska Kosa

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

General Hospital Leskovac

Leskovac, , Serbia

Clinical Center Nis

Niš, , Serbia

General Hospital Djordje Joanovic, Internal Deases Department, Gastroenterology

Zrenjanin, , Serbia

Hospital Juan Ramón Jimenez

Huelva, , Spain

Bezmiâlem Vakıf Üniversitesi

Fatih, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Gastroenteroloji Bilim Dali

Fatih, , Turkey (Türkiye)

Karadeniz Teknik Üniversitesi Tip Fakultesi

Trabzon, , Turkey (Türkiye)

Public Enterprise "Dnipropetrovsk regional clinical hospital named after I.I. Mechnikova", Department of Gastroenterology (Hepatology)

Dnipro, , Ukraine

MNPE "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Gastroenterology Department, SHEI "Ivano-Frankivsk National Medical University", Chair of Internal Medicine #1

Ivano-Frankivsk, , Ukraine

Ivano-Frankivsk City Clinical Hospital No. 1

Ivano-Frankivsk, , Ukraine

Municipal Non-profit Enterprise "City Clinical Hospital #2 named after prof. O.O. Shalimova", of Kharkiv City Council, Proctology Department

Kharkiv, , Ukraine

Municipal Non-profit Enterprise of Kharkiv Regional Council "Regional Clinical Hospital", Gastroenterology Department

Kharkiv, , Ukraine

Private Enterprise Private Manufacturing Firm "Acinus", Treatment and diagnostic Centre

Kropyvnytskyi, , Ukraine

Medical Center Medical Clinic Blagomed LLC

Kyiv, , Ukraine

Kyiv City Clinical Hospital #18, Proctology Department, National Medical University named after O.O.Bogomolets, Chair of Surgery #1

Kyiv, , Ukraine

Kyiv City Clinical Hospital #1, Therapeutics Department #2

Kyiv, , Ukraine

Medical Centre of Limited Liability Company "Medical Centre "Dopomoga plus""

Kyiv, , Ukraine

Shalimov's National Institute of surgery and transplantation

Kyiv, , Ukraine

Medical Centre of Limited Liability Company "Medical Centre "Consilium Medical", clinico-consultation department

Kyiv, , Ukraine

Kyiv Regional Clinical Hospital No 2

Kyiv, , Ukraine

Volyn Regional Clinical Hospital

Lutsk, , Ukraine

Municipal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", proctology department, Danylo Galytsky Lviv National Medical University, Chair of Surgery #1

Lviv, , Ukraine

KARDIOKOM Ltd.

Mykolaiv, , Ukraine

Transcarpathian Regional Clinical Hospital named after Andriy Novaka, gastroenterology department

Uzhhorod, , Ukraine

Municipal Non-profit Enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pyrogova of Vinnytsia Regional Council, Regional Specialized Clinical Gastroenterological Center,

Vinnytsia, , Ukraine

Municipal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1, Gastroenterology Department, Vinnytsia National Medical University named after M.I.Pyrogova, Chair of Propaedeutics of Internal Medicine

Vinnytsia, , Ukraine

Municipal Institution "Zaporizhzhska Regional Clinical Hospital" of Zaporizhzha Regional Council, gastroenterology department

Zaporizhzhya, , Ukraine

London North West University Healthcare NHS Trust (LNWH), St Mark's Hospital, R&D Department, Northwick Park Hospital

Harrow, , United Kingdom

Barts Health NHS Trust, of Royal London Hospital

London, , United Kingdom

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital

Prescot, , United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust, University Hospital

Shrewsbury, , United Kingdom

Shrewsbury and Telford Hospitals NHS Trust, Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

The Royal Wolverhampton NHS Trust, New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Albania; Belarus; Bosnia and Herzegovina; Bulgaria; Croatia; Czechia; Georgia; Netherlands; North Macedonia; Poland; Portugal; Romania; Russia; Serbia; Spain; Turkey (Türkiye); Ukraine; United Kingdom

References

D'Haens G, Stardelova KG, Sadiku E, Kizlova N, Skybalo S, Shehovtsova Y, Abramescu M, Vitt D, Kohlhof H, Muehler A. Vidofludimus Calcium in Patients With Moderate-to-Severe Ulcerative Colitis: A Randomized, Placebo-Controlled, Phase 2 Trial. Clin Transl Gastroenterol. 2025 Mar 1;16(3):e00813. doi: 10.14309/ctg.0000000000000813.

Reference Type: DERIVED

PMID: 39791563 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf

European Medicines Agency (EMA). Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis.\[Online\]. 2016.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM515143.pdf

US Food and Drug Administration (FDA). Ulcerative Colitis: Clinical Trial Endpoints. Guidance for Industry.\[Online\]. 2016.

https://www.auanet.org/guidelines-and-quality/guidelines/microhematuria

American Urological Association. Guideline: Diagnosis, evaluation and follow up of asymptomatic mircrohematuria. (AMH) in adults.\[Online\]. 2012.

http://eurlex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31995L0046

European Union (EU). Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. \[Online\].

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0679

EU. Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). 2016; \[Online\].

Other Identifiers

P2-IMU-838-UC

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003703-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P2-IMU-838-UC

Identifier Type: -

Identifier Source: org_study_id