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

NCT03178669 | Completed Phase 2 Results DMC

• 2 other identifiers: CSUC-01/162016-004217-26
• Study Type: interventional
• Target: 213
• Locations: 9 countries
• Sites: 63

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.

Conditions

Ulcerative Colitis

Keywords

Colitis, Ulcerative; Gastrointestinal Diseases; Inflammatory Bowel Disease; Immunomodulator Therapy; Glucocorticoids; Anti-Inflammatory Agents; Therapeutic uses; Kappaproct; IDX0150; DIMS0150

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks after first treatment

Secondary Outcomes (5)

• Modified Clinical Remission

  Week 6

• Symptomatic Remission

  Week 6

• Clinical Response

  Week 6

• Endoscopic Remission

  Week 6

• Histological Remission

  Week 6

Study Arms (5)

Cobitolimod Dose 2x31 mg

EXPERIMENTAL

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

Drug: cobitolimod

Cobitolimod Dose 2x125 mg

EXPERIMENTAL

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

Drug: cobitolimod

Cobitolimod Dose 2x250 mg

EXPERIMENTAL

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

Drug: cobitolimod

Cobitolimod Dose 4x125 mg

EXPERIMENTAL

Dose 125 mg of cobitolimod, at 4 occasions

Drug: cobitolimod

Placebo

PLACEBO COMPARATOR

Placebo at four occasions

Drug: Placebo

Interventions

cobitolimod DRUG

Rectal administration

Also known as: Kappaproct

Cobitolimod Dose 2x125 mg; Cobitolimod Dose 2x250 mg; Cobitolimod Dose 2x31 mg; Cobitolimod Dose 4x125 mg

Placebo DRUG

Solution manufactured to mimic cobitolimod

Also known as: Placebo (for cobitolimod)

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InDex Pharmaceuticals: lead

Study Sites (64)

1

Prague, Czechia

Location

2

Amiens, France

Location

3

Caen, France

Location

4

Clichy, France

Location

5

Grenoble, France

Location

6

Nice, France

Location

7

Pierre-Bénite, France

Location

8

Saint-Etienne, France

Location

9

Toulouse, France

Location

10

Vandœuvre-lès-Nancy, France

Location

11

Augsburg, Germany

Location

12

Berlin, Germany

Location

13

Erlangen, Germany

Location

14

Hamburg, Germany

Location

15

Hanover, Germany

Location

16

Heidelberg, Germany

Location

17

Leipzig, Germany

Location

18

Lüneburg, Germany

Location

19

Mannheim, Germany

Location

20

München, Germany

Location

22

Békéscsaba, Hungary

Location

21

Budapest, Hungary

Location

23

Debrecen, Hungary

Location

24

Mosonmagyaróvár, Hungary

Location

25

Pécs, Hungary

Location

26

Częstochowa, Poland

Location

27

Krakow, Poland

Location

28

Ksawerów, Poland

Location

33

Lodz, Poland

Location

29

Lublin, Poland

Location

30

Poznan, Poland

Location

31

Sopot, Poland

Location

32

Warsaw, Poland

Location

33

Wroclaw, Poland

Location

32

Włocławek, Poland

Location

34

Cheboksary, Russia

Location

36

Kazan', Russia

Location

37

Kirov, Russia

Location

38

Moscow, Russia

Location

39

Novosibirsk, Russia

Location

40

Ryazan, Russia

Location

41

Saint Petersburg, Russia

Location

42

Stavropol, Russia

Location

43

Tver', Russia

Location

44

Ufa, Russia

Location

35

Yekaterinburg, Russia

Location

45

Belgrade, Serbia

Location

46

Ferrol, Spain

Location

47

Fuenlabrada, Spain

Location

48

Madrid, Spain

Location

49

Seville, Spain

Location

50

Valencia, Spain

Location

51

Uppsala, Sweden

Location

52

Chernivtsi, Ukraine

Location

53

Dnipro, Ukraine

Location

54

Ivano-Frankivsk, Ukraine

Location

55

Kharkiv, Ukraine

Location

56

Kiev, Ukraine

Location

57

Lutsk, Ukraine

Location

58

Lviv, Ukraine

Location

59

Odesa, Ukraine

Location

60

Sumy, Ukraine

Location

62

Uzhhorod, Ukraine

Location

61

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 33031757 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Gastrointestinal Diseases; Inflammatory Bowel Diseases

Interventions

cobitolimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Karin Arnesson, Clinical Trial Manager
• Organization: InDex Pharmaceuticals

karin.arnesson@indexpharma.com

+46 8 122 038 57

Study Officials

• Raja Atreya

  Friedrich-Alexander University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: June 21, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: February 1, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5); SE (1); PL (10); FR (9); CZ (1); DE (10); RU (11); UA (11); ES (5)