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AzTrials

Ulcerative ColitisPhase 3CONCLUDENCT04985968

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

A Phase 3 study testing Cobitolimod 250 mg and Cobitolimod 500 mg in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 203 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Cobitolimod 250 mg and Cobitolimod 500 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
203 sitesin 28 countries
Study dates
24 Nov 2021to 20 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years of age.
  • Established diagnosis of UC.
  • Moderate to severe active left-sided UC assessed by central reading.
  • Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
  • Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
  • Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
  • Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Who cannot join

  • Suspicion of differential diagnosis.
  • Acute fulminant UC and/or signs of systemic toxicity.
  • UC limited to the rectum or extending beyond the splenic flexure.
  • Have failed treatment with more than three advanced therapies of two different therapeutic classes.
  • Have had surgery for treatment of UC.
  • History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
Show all 17Show fewer
  • History or presence of any clinically significant disorder.
  • Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
  • Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
  • Long-term treatment (>14 days) with antibiotics or NSAIDs .
  • Serious known active infection including history of latent or active tuberculosis.
  • Gastrointestinal infections including positive Clostridium difficile stool assay.
  • Females who are lactating or have a positive serum pregnancy test.
  • Women of childbearing potential not using highly effective contraceptive methods.
  • Concurrent participation in another clinical study.
  • Previous exposure to cobitolimod.
  • Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

Trial locations and contacts

203 sites in 28 countries.

203 sites in 28 countries

United States25 sites

  • Dayton Gastroenterology

    Beavercreek, Ohio, 45440

  • RecioMed Clinical Research Network, Inc.

    Boynton Beach, Florida, 33472

  • Digestive Health Associates of Texas, PA

    Carrollton, Texas, 75019

  • Carolina Digestive Health Associates, PA

    Charlotte, North Carolina, 28209

  • MB & V Medical Research

    Doral, Florida, 33172

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Amicis Research Center

    Granada Hills, California, 91344

  • Carolina Research

    Greenville, North Carolina, 27834

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Clinical Research Solution: Digestive Health Associates

    Houston, Texas, 77024

  • Baylor College of Medicine - Gastroeneterology

    Houston, Texas, 77030

  • A+ Research, Inc.

    Miami, Florida, 33012

  • SouthCoast Research Center, Inc

    Miami, Florida, 33136

  • I.V.A.M. Clinical & Investigational Center LLC

    Miami, Florida, 33144

  • D&H National Research Centers, Inc.

    Miami, Florida, 33155

  • Medical Professionals Clinical Research Center

    Miami, Florida, 33165

  • Wisconsin Center For Advanced Research

    Milwaukee, Wisconsin, 53215

  • Allameh Medical Corporation

    Mission Viejo, California, 92691

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102

  • Lenox Hill Hospital

    New York, New York, 10075

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730

  • Alliance Clinical Research - Gastroenterology

    Tampa, Florida, 33615

  • Valiance Clinical Research

    Tarzana, California, 91356

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Clinical Research Institute of Michigan

    Troy, Michigan, 48098

Other trials in United States

Poland19 sites

  • MPS - MED sp. z o.o.

    Grudziądz

  • MZ Badania Slowik Zymla Spolka jawna

    Knurów

  • Centrum Medyczne Plejady

    Krakow

  • Centrum Medyczne PROMED

    Krakow

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow

  • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

    Lodz

  • Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

    Malbork

  • Twoja Przychodnia - Opolskie Centrum Medyczne

    Opole

  • Medicome Sp. z o.o.

    Oświęcim

  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan

  • ETG Skierniewice

    Skierniewice

  • KO-MED Centra Kliniczne Staszow

    Staszów

  • Twoja Przychodnia - SCM

    Szczecin

  • GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie

    Torun

  • Bodyclinic sp. z o.o. sp.k.

    Warsaw

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warsaw

  • PlanetMed

    Wroclaw

  • ETG Zamosc

    Zamość

Other trials in Poland

Germany16 sites

  • Universitätsklinikum Augsburg

    Augsburg

  • Charité - Universitätsmedizin Berlin KöR

    Berlin

  • University Hospital Cologne AöR

    Cologne

  • MVZ Sanaklinikum Duisburg

    Duisburg

  • Universitätsklinikum Erlangen

    Erlangen

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main

  • Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I

    Frankfurt am Main

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Uniklinik Halle (Saale)

    Halle

  • Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt

    Heidelberg

  • University Hospital Schleswig-Holstein

    Kiel

  • Universitätsmedizin Mannheim

    Mannheim

  • Medius Klinik Nürtingen

    Nürtingen

  • Universitätsklinikum Rostock

    Rostock

  • Universitätsklinikum Ulm

    Ulm

  • Internistische Praxis Weyhe

    Weyhe

Other trials in Germany

Italy12 sites

  • ASST Papa Giovanni XXIII - Cardiologia - Bergamo

    Bergamo

  • AO Brotzu

    Cagliari

  • Universita degli Studi di Firenze - Azienda Ospedaliero - Un

    Florence

  • IRCCS Ospedale San Raffaele

    Milan

  • Azienda Ospedaliera San Gerardo

    Monza

  • AOU di Padova

    Padova

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P

    Roma

  • Policlinico Universitario Agostino Gemelli

    Roma

  • Policlinico Universitario Campus Biomedico

    Rome

  • A.O. Ordine Mauriziano Di Torino

    Torino

  • AOU S. Maria della Misericordia

    Udine

  • Universita degli Studi dell'Insubria - Ospedale di Circolo e

    Varese

Other trials in Italy

France11 sites

  • CHRU de Lille - Hôpital Claude Huriez

    Lille

  • CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie

    Montpellier

  • CHU de Nancy Brabois

    Nancy

  • CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie

    Nice

  • Hopital Bichat - Gastroenterology

    Paris

  • Hopital Saint Antoine

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie

    Saint-Etienne

  • CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog

    Salouël

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse

Other trials in France

South Korea10 sites

  • Inje University Haeundae Paik Hospital

    Busan

  • Kyungpook National University Hospital

    Daegu

  • Hanyang University Guri Hospital

    Guri-si

  • Kyung Hee University Hospital

    Seoul

  • Seoul National University Bundang Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Kyung Hee University Hospital - Internal Medicine

    Soeul

  • Kyung Hee University Hospital

    Soeul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

United Kingdom10 sites

  • Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology

    Bury

  • Accellacare Warwickshire Quality Research Site

    Coventry

  • County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital

    Darlington

  • Glasgow Royal Infirmary

    Glasgow

  • North West London Hospitals NHS Trust

    Harrow

  • Central Middlesex Hospital

    London

  • Kings College Hospital

    London

  • Accellacare North London

    Northwood

  • Accellacare Limited/Accellacare of South London

    Orpington

  • Royal Berkshire Hospital

    Reading

Other trials in United Kingdom

Bosnia and Herzegovina8 sites

  • University Clinical Centre of the Republic of Srpska - Gastroenterology

    Banja Luka

  • The University Hospital Foca

    Foca

  • Clinical Center University of Sarajevo - Gastroenterology

    Sarajevo

  • General Hospital "Prim.dr.Abdulah Nakas"

    Sarajevo

  • Polyclinic Dr. Al-Tawil

    Sarajevo

  • Opca Bolnica Tesanj

    Tešanj

  • Plava Medical Group

    Tuzla

  • Cantonal Hospital Zenica

    Zenica

Other trials in Bosnia and Herzegovina

Serbia7 sites

  • Clinic Center of Serbia

    Belgrade

  • Clinical Hospital Center "Dr. Dragisa Misovic"

    Belgrade

  • Euromedik Hospital

    Belgrade

  • Zvezdara University Medical Center

    Belgrade

  • Clinical Center Kragujevac - Center for Gastroenterohepatology

    Kragujevac

  • General Hospital Dr Djordje Joanovic

    Zrenjanin

  • General hospital Zrenjanin

    Zrenjanin

Other trials in Serbia

Australia6 sites

  • Monash Health

    Clayton

  • St Vincent's Hospital Melbourne

    Fitzroy

  • The Alfred Hospital

    Melbourne

  • Royal Melbourne Hospital

    Parkville

  • Mater Health Services

    South Brisbane

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

Belgium6 sites

  • UZ Antwerpen

    Antwerp

  • Imelda Ziekenhuis

    Bonheiden

  • Erasme University Hospital

    Brussels

  • Universitair Ziekenhuis Gent

    Ghent

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk

  • AZ Delta

    Roeselare

Other trials in Belgium

Brazil6 sites

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia

  • Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

    Porto Alegre

  • Ufrj - Hospital Universitario Clementino Fraga Filho

    Rio de Janeiro

  • Praxis Pesquisa Medica

    Santo André

  • CEMEC - Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo

  • Kaiser Clinica

    São José do Rio Preto

Other trials in Brazil

Croatia6 sites

  • Opca bolnica Bjelovar

    Bjelovar

  • Clinical Hospital Osijek

    Osijek

  • Opca bolnica Pula

    Pula

  • Zadar General Hospital

    Zadar

  • Poliklinika Solmed

    Zagreb

  • University Hospital Centre Zagreb

    Zagreb

Other trials in Croatia

Israel6 sites

  • The Barzilai Medical Center

    Ashkelon

  • The Edith Wolfson Medical Center

    Holon

  • Hadassah Medical Organization, Hadassah Medical Center, Ein-

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Galilee Medical Center (Western Galilee Hospital)

    Nahariya

  • Kaplan Medical Center

    Rehovot

Other trials in Israel

Romania6 sites

  • Sana Monitoring

    Bucharest

  • Spitalul Clinic Colentina

    Bucharest

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca

  • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi

    Iași

  • Spitalul Clinic Judetean Mures

    Târgu Mureş

  • Cabinet Particular Policlinic Algomed

    Timișoara

Other trials in Romania

Denmark5 sites

  • Aalborg University Hospital

    Aalborg

  • Aarhus University Hospital

    Aarhus

  • Herlev Hospital

    Herlev

  • Hillerod Hospital

    Hillerød

  • Lillebælt Hospital Vejle

    Vejle

Other trials in Denmark

Hungary5 sites

  • Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.

    Budapest

  • Pannónia Magánorvosi Centrum Kft

    Budapest

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

    Budapest

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar

    Budapest

  • SzTE Szt-Gy A Orvostud Kar Bel Klin

    Szeged

Other trials in Hungary

Lithuania5 sites

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas

  • Klaipeda Seamen's Hospital

    Klaipėda

  • Republic Klaipeda Hospital

    Klaipėda

  • Panevezio ligonine

    Panevezys

  • Vilniaus Universiteto ligonines Santariskiu Klinikos

    Vilnius

Other trials in Lithuania

Mexico5 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango

  • Medical Care and Research S. A. de C. V

    Mérida

  • Clinicos Asociados Bocm, S.C.

    Mexico City

  • Centro Regiomontano de Estudios Clinicos Roma SC

    Monterrey

  • Clinical Research Institute S.C.

    Tlalnepantla

Other trials in Mexico

Slovakia5 sites

  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica

  • CLINIQ s.r.o.

    Bratislava

  • ENDOMED s.r.o.

    Košice

  • GASTROMEDIC, s.r.o.

    Nové Zámky

  • Accout Center s.r.o.

    Šahy

Other trials in Slovakia

Austria4 sites

  • MedUn Innsbruck

    Innsbruck

  • LKH Klagenfurt

    Klagenfurt

  • Universitätsklinikum Salzburg

    Salzburg

  • Akh Wien

    Vienna

Other trials in Austria

Norway4 sites

  • Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR

    Ålesund

  • Akershus Universitetssykehus

    Lørenskog

  • Vestfold Hjertesenter As

    Tønsberg

  • Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8

    Tromsø

Other trials in Norway

Portugal4 sites

  • Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)

    Amadora

  • Hospital de Braga

    Braga

  • Hospital Beatriz Angelo (HBA)

    Loures

  • Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião

    Santa Maria da Feira

Other trials in Portugal

Canada3 sites

  • MUMC - Hamilton Health Sciences

    Hamilton

  • Installation Hospital Maisonneuve-Rosemont

    Montreal

  • Royal University Hospital

    Saskatoon

Other trials in Canada

Sweden3 sites

  • Örebro Univ. Hospital

    Örebro

  • Karolinska Universitetssjukhuset - Gastroenterology

    Stockholm

  • Uppsala University Hospital, Akademiska

    Uppsala

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Hacettepe University Medical Faculty - Hematology

    Ankara

  • Istanbul University Medical Faculty

    Istanbul

  • Mersin Universtiy Medical Faculty

    Mersin

Other trials in Turkey (Türkiye)

Georgia2 sites

  • JSC " Evex Hospitals"

    Batumi

  • LTD Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi

Other trials in Georgia

Netherlands1 site

  • Radboud University Medical Center

    Nijmegen

Other trials in Netherlands

About this study

Official title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

Read the detailed description

This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.

In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.

Being tested
Cobitolimod 250 mg, Cobitolimod 500 mg, Placebo
Keywords
Colitis, Ulcerative, Gastrointestinal Disease, Inflammatory Bowel Diseases, Glucocorticosteroids, Anti-Inflammatory Agents, Therapeutic uses, Cobitolimod, Toll like receptor 9 agonist, TLR9 agonist, Kappaproct, IDX0150, DIMS0150
Medical subject headings
Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cobitolimod 250 mgDrug

    Also called Kappaproct

    Rectal administration

  • Cobitolimod 500 mgDrug

    Also called Kappaproct

    Rectal administration

  • PlaceboDrug

    Rectal administration

Study groups in NCT04985968
Study groupRoleWhat they receive
Cobitolimod 250 mgExperimentalDose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week
Receives: Drug: Cobitolimod 250 mg
Cobitolimod 500 mgExperimentalDose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
Receives: Drug: Cobitolimod 500 mg
PlaceboPlacebo comparatorDose of Placebo 2 treatments during induction study and subsequently every third week
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Induction - Proportion of participants with clinical remission.

    Clinical remission defined by the 3-component Mayo score.

    Measured: Week 6

  2. Maintenance - Proportion of participants with clinical remission.

    Clinical remission defined by the 3-component Mayo score.

    Measured: Week 52

Secondary outcomes (28)

  1. Induction - Proportion of participants with endoscopic improvement.

    Endoscopic improvement defined by the Mayo Endoscopic score.

    Measured: Week 6

  2. Induction - Proportion of participants with symptomatic remission.

    Symptomatic remission defined by the 2-component Mayo score.

    Measured: Week 6

  3. Induction - Proportion of participants with clinical response.

    Clinical remission defined by the 3-component Mayo score.

    Measured: Week 6

  4. Induction - Proportion of participants with normalisation of stool frequency.

    Stool frequency defined by the Mayo score for Stool Frequency.

    Measured: Week 6

  5. Induction - Proportion of participants with absence of rectal bleeding.

    Rectal bleeding defined by the Mayo score for Rectal Bleeding.

    Measured: Week 6

  6. Induction - Mean stool frequency.

    Mean stool frequency defined by the Mayo score for Stool Frequency.

    Measured: Week 6

  7. Induction - Proportion of participants with histologic improvement.

    Defined by the Robarts Histologic Index.

    Measured: Week 6

  8. Induction - Proportion of participants with histologic remission.

    Histologic remission defined by the Robarts Histologic Index.

    Measured: Week 6

  9. Induction - Proportion of participants with mucosal healing.

    Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.

    Measured: Week 6

  10. Induction - Mean ln-transformed faecal calprotectin.

    Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.

    Measured: Week 6

  11. Induction - Mean 3-component and 4-component Mayo scores.

    Defined by 3-component and 4-component Mayo scores.

    Measured: Week 6

  12. Induction - Mean IBDQ total score.

    Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).

    Measured: Week 6

  13. Induction - Proportion of participants with an improvement in IBDQ total score.

    Defined by the IBDQ.

    Measured: Week 6

  14. Maintenance - Proportion of participants with endoscopic improvement.

    Endoscopic improvement defined by the Mayo Endoscopic score.

    Measured: Week 52

  15. Maintenance - Proportion of participants with clinical remission and steroid-free.

    Defined by the 3-component Mayo score and use of glucocorticosteroids.

    Measured: Week 52

  16. Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission

    Defined by the 3-component Mayo score.

    Measured: Week 52

  17. Maintenance - Proportion of participants with symptomatic remission.

    Symptomatic remission defined by the 2-component Mayo score.

    Measured: Week 52

  18. Maintenance - Proportion of participants with histologic improvement.

    Histologic improvement defined by the Robarts Histologic Index.

    Measured: Week 52

  19. Maintenance - Proportion of participants with histologic remission.

    Histologic remission defined by the Robarts Histologic Index.

    Measured: Week 52

  20. Maintenance - Proportion of participants with mucosal healing.

    Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.

    Measured: Week 52

  21. Maintenance - Proportion of participants with clinical response.

    Clinical response defined by the 3-component Mayo score.

    Measured: Week 52

  22. Maintenance - Proportion of participants with absence of rectal bleeding.

    Rectal bleeding defined by the Mayo score for Rectal Bleeding.

    Measured: Week 52

  23. Maintenance - Proportion of participants with normalisation of stool frequency.

    Stool frequency defined by the Mayo score for Stool Frequency.

    Measured: Week 52

  24. Maintenance - Mean stool frequency.

    Mean stool frequency defined by the Mayo score for Stool Frequency.

    Measured: Week 52

  25. Maintenance - Mean ln-transformed faecal calprotectin.

    Mean ln-transformed faecal calprotectin.

    Measured: Week 52

  26. Maintenance - Mean 3-component and 4-component Mayo scores.

    Defined by 3-component and 4-component Mayo scores.

    Measured: Week 52

  27. Maintenance - Mean IBDQ total score.

    Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).

    Measured: Week 52

  28. Maintenance - Proportion of participants with an improvement in IBDQ total score.

    Defined by the IBDQ.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start24 Nov 2021
  3. Primary completion20 Dec 2023
  4. Study completion20 Dec 2023

Why it stopped: Due to futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04985968
Sponsor's protocol ID
CSUC-01/21
Acronym
CONCLUDE
Status last verified
Dec 2023
First submitted
22 Jul 2021
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cobitolimod 250 mg and Cobitolimod 500 mg in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 203 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, Poland, Germany, Italy, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction - Proportion of participants with clinical remission. (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.

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