Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

NCT03341962 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: P2-IMU-838-UC2017-003703-22
• Study Type: interventional
• Target: 263
• Locations: 19 countries
• Sites: 131

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).

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; IMU-838; vidofludimus calcium

Outcome Measures

Primary Outcomes (1)

• Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10

  Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint

  10 weeks

Secondary Outcomes (41)

• Induction Phase: Symptomatic Remission and Endoscopic Healing at Different Doses at Week 10

  10 weeks

• Induction Phase: Symptomatic Remission

  22 weeks

• Induction Phase: Time to Achieving Symptomatic Remission

  22 weeks

• Induction Phase: Proportion of Patients With Clinical Response

  10 weeks

• Induction Phase: Proportion of Patients With Endoscopic Healing

  10 weeks

Study Arms (8)

10 mg IMU-838 (Induction)

EXPERIMENTAL

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.

Drug: IMU-838

30 mg IMU-838 (Induction)

EXPERIMENTAL

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.

Drug: IMU-838

45 mg IMU-838 (Induction)

EXPERIMENTAL

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.

Drug: IMU-838

placebo (Induction)

PLACEBO COMPARATOR

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

Drug: Placebo

10 mg IMU-838 (Maintenance)

EXPERIMENTAL

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

Drug: IMU-838

30 mg IMU-838 (Maintenance)

EXPERIMENTAL

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

Drug: IMU-838

placebo (Maintenance)

PLACEBO COMPARATOR

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

30 mg IMU-838 (Open-label)

EXPERIMENTAL

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

Drug: IMU-838

Interventions

IMU-838 DRUG

IMU-838 tablet

Also known as: IM90838, vidofludimus calcium

10 mg IMU-838 (Induction); 10 mg IMU-838 (Maintenance); 30 mg IMU-838 (Induction); 30 mg IMU-838 (Maintenance); 30 mg IMU-838 (Open-label); 45 mg IMU-838 (Induction)

Placebo DRUG

Tablets manufactured to mimic IMU-838 tablets

Also known as: Placebo (for IMU-838)

placebo (Induction); placebo (Maintenance)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Immunic AG: lead

Study Sites (131)

Del Sol Research Management, LLC

Tucson, Arizona, 85710, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Alliance Medical Research, LLC

Lighthouse PT, Florida, 33071, United States

Location

Medley Research Associates

Medley, Florida, 33166, United States

Location

Global Life Research LLC

Miami, Florida, 33155-4630, United States

Location

Family Clinical Trials

Pembroke Pines, Florida, 33026-3240, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30308, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States

Location

PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406-7132, United States

Location

First Street Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Digestive Health Specialists

Tacoma, Washington, 98405, United States

Location

Durres Regional Hospital

Durrës, 2001, Albania

Location

Regional Hospital of Shkoder

Shkodër, 4001, Albania

Location

University Hospital Center Mother Teresa

Tirana, 1000, Albania

Location

Gomel Regional Clinical Hospital

Homyel, 246029, Belarus

Location

Republican Scientific and Practical Center for Radiation Medicine and Human Ecology

Homyel, 246040, Belarus

Location

Vitiebsk State Order of Peoples' Friendship Medical University

Vitebsk, 210009, Belarus

Location

University Clinical Centre of the Republic of Srpska, Internal Medicine Clinic, Department of Gastroenterology and Hepatology

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Clinical Hospital Mostar, Internal Medicine Clinic, Department of Gastroenterology

Mostar, 88000, Bosnia and Herzegovina

Location

Multiprofile Hospital for Active Treatment Blagoevgrad AD

Blagoevgrad, 2700, Bulgaria

Location

Mhat Byala

Byala, 187100, Bulgaria

Location

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

Kazanlak, 6100, Bulgaria

Location

Medical Center "Medconsult Pleven" OOD

Pleven, 5800, Bulgaria

Location

Medical Center Exacta Medica

Pleven, 5800, Bulgaria

Location

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

Plovdiv, 4002, Bulgaria

Location

Medical Center "Hera" EOOD

Sofia, 1510, Bulgaria

Location

Diagnostic-Consulting Center "Convex" EOOD

Sofia, 1680, Bulgaria

Location

General Hospital Bjelovar

Bjelovar, 43000, Croatia

Location

Clinical Hospital Center Osijek

Osijek, 31000, Croatia

Location

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

Location

Clinical Hospital Center Split

Split, 21000, Croatia

Location

General Hospital Vukovar

Vukovar, 32000, Croatia

Location

Clinical Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Location

Polyclinic Solmed Zagreb

Zagreb, 10000, Croatia

Location

Clinical Hospital Center Split

Zagreb, 21000, Croatia

Location

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

Havířov, 73601, Czechia

Location

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

Hradec Králové, 50012, Czechia

Location

Artroscan s.r.o.

Ostrava - Třebovice, 72200, Czechia

Location

FaraCol s.r.o. - Prague

Prague, 10100, Czechia

Location

MEDICON a.s. - Poliklinika Budějovická Gastroenterologie

Prague, 14000, Czechia

Location

Klinika ResTrial

Prague, 14300, Czechia

Location

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

Prague, 17004, Czechia

Location

Academician Z.Tskhakaia West Georgia National Center of Interventional Medicine

Kutaisi, 4600, Georgia

Location

LTD Unimedi Kakheti - Caraps Medline

Tbilisi, 0159, Georgia

Location

Amsterdam UMC, locatie AMC

Amsterdam, 1105 AZ, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, 3318 AT, Netherlands

Location

Elisabeth-TweeSteden Hospital

Tilburg, 5022 GC, Netherlands

Location

City General Hospita 8th September

Skopje, 1000, North Macedonia

Location

University Clinic for Hematology - Skopje - Macedonian Hematology Association

Skopje, 1131, North Macedonia

Location

Centrum Usług Medycznych MaxMed

Bochnia, 32700, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81338, Poland

Location

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

Karczew, 05480, Poland

Location

Vita Longa Sp. z o.o.

Katowice, 40748, Poland

Location

GLOBE Badania Kliniczne Sp. z o.o.

Kłodzko, 57300, Poland

Location

Salve Medica Sp. z o.o. Spółka Komandytowa

Lodz, 91211, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddział Gastroenterologii

Lublin, 20954, Poland

Location

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

Nowy Targ, 34400, Poland

Location

Etyka Ośrodek Badań Klinicznych

Olsztyn, 10117, Poland

Location

Ars Medical - Szpital, Ars Medical - Ambulatorium

Piła, 64920, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60529, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Centrum Medyczne HCP - Lecznictwo Stacjonarne

Poznan, 61485, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81756, Poland

Location

Klinika Medifem

Warsaw, 02-884, Poland

Location

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

Warsaw, 02679, Poland

Location

Przychodnia Vistamed

Wroclaw, 53149, Poland

Location

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

Wroclaw, 54204, Poland

Location

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

Łódz, 91034, Poland

Location

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

Coimbra, 3000-075, Portugal

Location

Hospital da Senhora da Oliveira - Guimarães, EPE

Guimarães, 4835-044, Portugal

Location

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

Santa Maria da Feira, 4520-211, Portugal

Location

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

Bucharest, 10719, Romania

Location

Spitalul Clinic Colentina, Sectia Gastroenterologie

Bucharest, 20125, Romania

Location

Institutul Clinic Fundeni, Sectia Clinica Gastroenterologie III

Bucharest, 22328, Romania

Location

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

Timișoara, 300002, Romania

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

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

Krasnodar, 350072, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 119435, Russia

Location

Federal Medical Biophysical Center n.a. Burnazyan

Moscow, 123098, Russia

Location

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

Moscow, 129110, Russia

Location

Novosibirskiy Gastrocenter, LLC

Novosibirsk, 630007, Russia

Location

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

Saint Petersburg, 191015, Russia

Location

Hospital of Saint Martyr Elizaveta

Saint Petersburg, 195257, Russia

Location

Research Center Eco-Safety, LLC

Saint Petersburg, 196143, Russia

Location

Gastroenterological Center "Expert" LLC

Saint Petersburg, 196620, Russia

Location

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

Saint Petersburg, 197101, Russia

Location

City Hospital No. 5 - Sochi

Sochi, 354207, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"

Tomsk, 634063, Russia

Location

Clinic for gastroenterohepatology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zemun

Belgrade, 11070, Serbia

Location

University Hospital Center Bezaniska Kosa

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital Leskovac

Leskovac, 16000, Serbia

Location

Clinical Center Nis

Niš, 18000, Serbia

Location

General Hospital Djordje Joanovic, Internal Deases Department, Gastroenterology

Zrenjanin, 34000, Serbia

Location

Hospital Juan Ramón Jimenez

Huelva, Spain

Location

Bezmiâlem Vakıf Üniversitesi

Fatih, 34093, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Gastroenteroloji Bilim Dali

Fatih, 34093, Turkey (Türkiye)

Location

Karadeniz Teknik Üniversitesi Tip Fakultesi

Trabzon, 61080, Turkey (Türkiye)

Location

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

Dnipro, 49005, Ukraine

Location

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

Ivano-Frankivsk, 76008, Ukraine

Location

Ivano-Frankivsk City Clinical Hospital No. 1

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kharkiv, 61037, Ukraine

Location

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

Kharkiv, 61201, Ukraine

Location

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

Kropyvnytskyi, 25006, Ukraine

Location

Medical Center Medical Clinic Blagomed LLC

Kyiv, 01001, Ukraine

Location

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

Kyiv, 01030, Ukraine

Location

Kyiv City Clinical Hospital #1, Therapeutics Department #2

Kyiv, 02091, Ukraine

Location

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

Kyiv, 02132, Ukraine

Location

Shalimov's National Institute of surgery and transplantation

Kyiv, 03680, Ukraine

Location

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

Kyiv, 04050, Ukraine

Location

Kyiv Regional Clinical Hospital No 2

Kyiv, 04073, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, 43000, Ukraine

Location

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, 79010, Ukraine

Location

KARDIOKOM Ltd.

Mykolaiv, 08711, Ukraine

Location

Transcarpathian Regional Clinical Hospital named after Andriy Novaka, gastroenterology department

Uzhhorod, 88018, Ukraine

Location

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

Vinnytsia, 20128, Ukraine

Location

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, 21029, Ukraine

Location

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

Zaporizhzhya, 69600, Ukraine

Location

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

Harrow, HA1 3UJ, United Kingdom

Location

Barts Health NHS Trust, of Royal London Hospital

London, E1 1BB, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital

Prescot, L35 5DR, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust, University Hospital

Shrewsbury, CV2 2DX, United Kingdom

Location

Shrewsbury and Telford Hospitals NHS Trust, Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

The Royal Wolverhampton NHS Trust, New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39791563 DERIVED

Related Links

• European Medicines Agency (EMA). Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis.\[Online\]. 2016.
• US Food and Drug Administration (FDA). Ulcerative Colitis: Clinical Trial Endpoints. Guidance for Industry.\[Online\]. 2016.
• American Urological Association. Guideline: Diagnosis, evaluation and follow up of asymptomatic mircrohematuria. (AMH) in adults.\[Online\]. 2012.
• 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. \[Online\].
• 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; \[Online\].

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Andreas Muehler, MD
• Organization: Immunic AG

Andreas.Muehler@imux.com

004989

Study Officials

• Andreas Muehler

  Immunic Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 14, 2017
• Study Start: March 15, 2018
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Locations

BU (8); PL (18); BE (3); SE (7); PT (3); NL (3); GB (7); BO (2); NO (2); CR (9); GE (2); RO (4); ES (1); RU (14); AL (3); US (15); CZ (7); TU (3); UA (20)