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

NCT ID: NCT03178669

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2019-08-30

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).

Conditions

Ulcerative Colitis

Study Design

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

Study Groups

Cobitolimod Dose 2x31 mg

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

Group Type: EXPERIMENTAL

cobitolimod

Intervention Type: DRUG

Rectal administration

Cobitolimod Dose 2x125 mg

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

Group Type: EXPERIMENTAL

cobitolimod

Intervention Type: DRUG

Rectal administration

Cobitolimod Dose 2x250 mg

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

Group Type: EXPERIMENTAL

cobitolimod

Intervention Type: DRUG

Rectal administration

Cobitolimod Dose 4x125 mg

Dose 125 mg of cobitolimod, at 4 occasions

Group Type: EXPERIMENTAL

cobitolimod

Intervention Type: DRUG

Rectal administration

Placebo

Placebo at four occasions

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution manufactured to mimic cobitolimod

Interventions

cobitolimod

Rectal administration

Intervention Type: DRUG

Placebo

Solution manufactured to mimic cobitolimod

Intervention Type: DRUG

Other Intervention Names

Kappaproct; Placebo (for cobitolimod)

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

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

Sponsors

InDex Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raja Atreya

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander University Erlangen-Nuremberg

Locations

1

Prague, , Czechia

2

Amiens, , France

3

Caen, , France

4

Clichy, , France

5

Grenoble, , France

6

Nice, , France

7

Pierre-Bénite, , France

8

Saint-Etienne, , France

9

Toulouse, , France

10

Vandœuvre-lès-Nancy, , France

11

Augsburg, , Germany

12

Berlin, , Germany

13

Erlangen, , Germany

14

Hamburg, , Germany

15

Hanover, , Germany

16

Heidelberg, , Germany

17

Leipzig, , Germany

18

Lüneburg, , Germany

19

Mannheim, , Germany

20

München, , Germany

22

Békéscsaba, , Hungary

21

Budapest, , Hungary

23

Debrecen, , Hungary

24

Mosonmagyaróvár, , Hungary

25

Pécs, , Hungary

26

Częstochowa, , Poland

27

Krakow, , Poland

28

Ksawerów, , Poland

33

Lodz, , Poland

29

Lublin, , Poland

30

Poznan, , Poland

31

Sopot, , Poland

32

Warsaw, , Poland

33

Wroclaw, , Poland

32

Włocławek, , Poland

34

Cheboksary, , Russia

36

Kazan', , Russia

37

Kirov, , Russia

38

Moscow, , Russia

39

Novosibirsk, , Russia

40

Ryazan, , Russia

41

Saint Petersburg, , Russia

42

Stavropol, , Russia

43

Tver', , Russia

44

Ufa, , Russia

35

Yekaterinburg, , Russia

45

Belgrade, , Serbia

46

Ferrol, , Spain

47

Fuenlabrada, , Spain

48

Madrid, , Spain

49

Seville, , Spain

50

Valencia, , Spain

51

Uppsala, , Sweden

52

Chernivtsi, , Ukraine

53

Dnipro, , Ukraine

54

Ivano-Frankivsk, , Ukraine

55

Kharkiv, , Ukraine

56

Kiev, , Ukraine

57

Lutsk, , Ukraine

58

Lviv, , Ukraine

59

Odesa, , Ukraine

60

Sumy, , Ukraine

62

Uzhhorod, , Ukraine

61

Zaporizhzhya, , Ukraine

Countries

Czechia; France; Germany; Hungary; Poland; Russia; Serbia; Spain; Sweden; Ukraine

References

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.

Reference Type: DERIVED

PMID: 33031757 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-004217-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSUC-01/16

Identifier Type: -

Identifier Source: org_study_id