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The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (CONDUCT)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cobitolimod
Placebo
Sponsored by
InDex Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Disease, Immunomodulator Therapy, Glucocorticoids, Anti-Inflammatory Agents, Therapeutic uses, Kappaproct, IDX0150, DIMS0150

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old
  • Established diagnosis of Ulcerative Colitis (UC)
  • Moderately to severely active left sided UC assessed by central reading
  • Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
  • Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

  • Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

    • Immunomodulators
    • Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

  • Suspicion of differential diagnosis
  • Acute fulminant UC and/or signs of systemic toxicity
  • UC limited to the rectum (disease which extend <15 cm above the anal verge)
  • History of malignancy
  • History or presence of any clinically significant disorder
  • Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
  • Treatment with rectal GCS, 5-ASA/SP or tacrolimus
  • Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Serious active infection
  • Gastrointestinal infections
  • Currently receiving parenteral nutrition or blood transfusions
  • Females who are lactating or have a positive serum pregnancy test
  • Women of childbearing potential not using reliable contraceptive methods
  • Concurrent participation in another clinical study
  • Previous exposure to cobitolimod

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cobitolimod Dose 2x31 mg

Cobitolimod Dose 2x125 mg

Cobitolimod Dose 2x250 mg

Cobitolimod Dose 4x125 mg

Placebo

Arm Description

Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions

Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions

Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions

Dose 125 mg of cobitolimod, at 4 occasions

Placebo at four occasions

Outcomes

Primary Outcome Measures

Clinical Remission
Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).

Secondary Outcome Measures

Modified Clinical Remission
Patients with modified clinical remission at Week 6 (yes=1, no=0), defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1
Symptomatic Remission
Patients with symptomatic remission at Week 6 (yes=1, no=0), defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)
Clinical Response
Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)
Endoscopic Remission
Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)
Histological Remission
Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1

Full Information

First Posted
June 5, 2017
Last Updated
January 12, 2021
Sponsor
InDex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03178669
Brief Title
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Acronym
CONDUCT
Official Title
A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InDex Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
Detailed Description
This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6. Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Disease, Immunomodulator Therapy, Glucocorticoids, Anti-Inflammatory Agents, Therapeutic uses, Kappaproct, IDX0150, DIMS0150

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cobitolimod Dose 2x31 mg
Arm Type
Experimental
Arm Description
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Arm Title
Cobitolimod Dose 2x125 mg
Arm Type
Experimental
Arm Description
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Arm Title
Cobitolimod Dose 2x250 mg
Arm Type
Experimental
Arm Description
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
Arm Title
Cobitolimod Dose 4x125 mg
Arm Type
Experimental
Arm Description
Dose 125 mg of cobitolimod, at 4 occasions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo at four occasions
Intervention Type
Drug
Intervention Name(s)
cobitolimod
Other Intervention Name(s)
Kappaproct
Intervention Description
Rectal administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for cobitolimod)
Intervention Description
Solution manufactured to mimic cobitolimod
Primary Outcome Measure Information:
Title
Clinical Remission
Description
Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).
Time Frame
6 weeks after first treatment
Secondary Outcome Measure Information:
Title
Modified Clinical Remission
Description
Patients with modified clinical remission at Week 6 (yes=1, no=0), defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1
Time Frame
Week 6
Title
Symptomatic Remission
Description
Patients with symptomatic remission at Week 6 (yes=1, no=0), defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)
Time Frame
Week 6
Title
Clinical Response
Description
Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)
Time Frame
Week 6
Title
Endoscopic Remission
Description
Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)
Time Frame
Week 6
Title
Histological Remission
Description
Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Established diagnosis of Ulcerative Colitis (UC) Moderately to severely active left sided UC assessed by central reading Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents: Immunomodulators Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins Exclusion Criteria: Suspicion of differential diagnosis Acute fulminant UC and/or signs of systemic toxicity UC limited to the rectum (disease which extend <15 cm above the anal verge) History of malignancy History or presence of any clinically significant disorder Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators Treatment with rectal GCS, 5-ASA/SP or tacrolimus Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) Serious active infection Gastrointestinal infections Currently receiving parenteral nutrition or blood transfusions Females who are lactating or have a positive serum pregnancy test Women of childbearing potential not using reliable contraceptive methods Concurrent participation in another clinical study Previous exposure to cobitolimod
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Atreya
Organizational Affiliation
Friedrich-Alexander University Erlangen-Nuremberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
1
City
Prague
Country
Czechia
Facility Name
2
City
Amiens
Country
France
Facility Name
3
City
Caen
Country
France
Facility Name
4
City
Clichy
Country
France
Facility Name
5
City
Grenoble
Country
France
Facility Name
6
City
Nice
Country
France
Facility Name
7
City
Pierre-Bénite
Country
France
Facility Name
8
City
Saint-Étienne
Country
France
Facility Name
9
City
Toulouse
Country
France
Facility Name
10
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
11
City
Augsburg
Country
Germany
Facility Name
12
City
Berlin
Country
Germany
Facility Name
13
City
Erlangen
Country
Germany
Facility Name
14
City
Hamburg
Country
Germany
Facility Name
15
City
Hanover
Country
Germany
Facility Name
16
City
Heidelberg
Country
Germany
Facility Name
17
City
Leipzig
Country
Germany
Facility Name
18
City
Lüneburg
Country
Germany
Facility Name
19
City
Mannheim
Country
Germany
Facility Name
20
City
München
Country
Germany
Facility Name
21
City
Budapest
Country
Hungary
Facility Name
22
City
Békéscsaba
Country
Hungary
Facility Name
23
City
Debrecen
Country
Hungary
Facility Name
24
City
Mosonmagyarovar
Country
Hungary
Facility Name
25
City
Pécs
Country
Hungary
Facility Name
26
City
Czestochowa
Country
Poland
Facility Name
27
City
Kraków
Country
Poland
Facility Name
28
City
Ksawerów
Country
Poland
Facility Name
29
City
Lublin
Country
Poland
Facility Name
30
City
Poznań
Country
Poland
Facility Name
31
City
Sopot
Country
Poland
Facility Name
32
City
Warszawa
Country
Poland
Facility Name
33
City
Wrocław
Country
Poland
Facility Name
32
City
Włocławek
Country
Poland
Facility Name
33
City
Łódź
Country
Poland
Facility Name
34
City
Cheboksary
Country
Russian Federation
Facility Name
35
City
Ekaterinburg
Country
Russian Federation
Facility Name
36
City
Kazan
Country
Russian Federation
Facility Name
37
City
Kirov
Country
Russian Federation
Facility Name
38
City
Moscow
Country
Russian Federation
Facility Name
39
City
Novosibirsk
Country
Russian Federation
Facility Name
40
City
Ryazan'
Country
Russian Federation
Facility Name
41
City
Saint Petersburg
Country
Russian Federation
Facility Name
42
City
Stavropol'
Country
Russian Federation
Facility Name
43
City
Tver
Country
Russian Federation
Facility Name
44
City
Ufa
Country
Russian Federation
Facility Name
45
City
Belgrad
Country
Serbia
Facility Name
46
City
Ferrol
Country
Spain
Facility Name
47
City
Fuenlabrada
Country
Spain
Facility Name
48
City
Madrid
Country
Spain
Facility Name
49
City
Sevilla
Country
Spain
Facility Name
50
City
Valencia
Country
Spain
Facility Name
51
City
Uppsala
Country
Sweden
Facility Name
52
City
Chernivtsi
Country
Ukraine
Facility Name
53
City
Dnipropetrovs'k
Country
Ukraine
Facility Name
54
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
55
City
Kharkiv
Country
Ukraine
Facility Name
56
City
Kiev
Country
Ukraine
Facility Name
57
City
Luts'k
Country
Ukraine
Facility Name
58
City
Lviv
Country
Ukraine
Facility Name
59
City
Odesa
Country
Ukraine
Facility Name
60
City
Sumy
Country
Ukraine
Facility Name
61
City
Zaporizhzhya
Country
Ukraine
Facility Name
62
City
Úzhgorod
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33031757
Citation
Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hebuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.
Results Reference
derived

Learn more about this trial

The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

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