Ulcerative ColitisPhase 2CONDUCTNCT03178669
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
A Phase 2 study testing cobitolimod in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 64 sites in 10 countries.
Trial 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. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 64 sitesin 10 countries
- Study dates
- 21 Jun 2017to 30 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
64 sites in 10 countries.
64 sites in 10 countries
Russia11 sites
34
Cheboksary
36
Kazan'
37
Kirov
38
Moscow
39
Novosibirsk
40
Ryazan
41
Saint Petersburg
42
Stavropol
43
Tver'
44
Ufa
35
Yekaterinburg
Ukraine11 sites
52
Chernivtsi
53
Dnipro
54
Ivano-Frankivsk
55
Kharkiv
56
Kiev
57
Lutsk
58
Lviv
59
Odesa
60
Sumy
62
Uzhhorod
61
Zaporizhzhya
Germany10 sites
11
Augsburg
12
Berlin
13
Erlangen
14
Hamburg
15
Hanover
16
Heidelberg
17
Leipzig
18
Lüneburg
19
Mannheim
20
München
Poland10 sites
26
Częstochowa
27
Krakow
28
Ksawerów
33
Lodz
29
Lublin
30
Poznan
31
Sopot
32
Warsaw
32
Włocławek
33
Wroclaw
France9 sites
2
Amiens
3
Caen
4
Clichy
5
Grenoble
6
Nice
7
Pierre-Bénite
8
Saint-Etienne
9
Toulouse
10
Vandœuvre-lès-Nancy
About this study
Official title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
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.
Read the 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
- Being tested
- cobitolimod, Placebo
- Keywords
- Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Disease, Immunomodulator Therapy, Glucocorticoids, Anti-Inflammatory Agents, Therapeutic uses, 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.
cobitolimodDrug
Also called Kappaproct
Rectal administration
PlaceboDrug
Also called Placebo (for cobitolimod)
Solution manufactured to mimic cobitolimod
| Study group | Role | What they receive |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Experimental | Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions Receives: Drug: cobitolimod |
| Cobitolimod Dose 2x125 mg | Experimental | Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions Receives: Drug: cobitolimod |
| Cobitolimod Dose 2x250 mg | Experimental | Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions Receives: Drug: cobitolimod |
| Cobitolimod Dose 4x125 mg | Experimental | Dose 125 mg of cobitolimod, at 4 occasions Receives: Drug: cobitolimod |
| Placebo | Placebo comparator | Placebo at four occasions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks after first treatment
Secondary outcomes (5)
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
Measured: Week 6
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)
Measured: Week 6
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)
Measured: Week 6
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)
Measured: Week 6
Histological Remission
Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start21 Jun 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- InDex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raja Atreya, Principal investigator, Friedrich-Alexander University Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178669
- Sponsor's protocol ID
- CSUC-01/16
- Other IDs
- 2016-004217-26, 2016
- Acronym
- CONDUCT
- Status last verified
- Jan 2021
- First submitted
- 5 Jun 2017
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33031757
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT03178669
- Acronym / sponsor ID
- CONDUCT / CSUC-01/16
- Conditions
- Ulcerative Colitis
- Keywords
- Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Disease, Immunomodulator Therapy, Glucocorticoids, Anti-Inflammatory Agents, Therapeutic uses, Kappaproct
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- InDex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Experimental | Drug: cobitolimodDose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
| Cobitolimod Dose 2x125 mg | Experimental | Drug: cobitolimodDose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
| Cobitolimod Dose 2x250 mg | Experimental | Drug: cobitolimodDose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
| Cobitolimod Dose 4x125 mg | Experimental | Drug: cobitolimodDose 125 mg of cobitolimod, at 4 occasions |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo at four occasions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cobitolimodAlso: KappaproctRectal administration | Drug | Cobitolimod Dose 2x125 mg, Cobitolimod Dose 2x250 mg, Cobitolimod Dose 2x31 mg, Cobitolimod Dose 4x125 mg |
| PlaceboAlso: Placebo (for cobitolimod)Solution manufactured to mimic cobitolimod | Drug | Placebo |
Primary outcome
Clinical Remission
Time frame: 6 weeks after first treatment
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).
5 secondary outcomes
Modified Clinical Remission
Time frame: Week 6
Symptomatic Remission
Time frame: Week 6
Clinical Response
Time frame: Week 6
Endoscopic Remission
Time frame: Week 6
Histological Remission
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33031757Atreya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Atreya principal investigator
Friedrich-Alexander University Erlangen-Nuremberg
64 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cobitolimod in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 64 sites in 10 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Russia, Ukraine, Germany, Poland, France and 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Remission (time frame: 6 weeks after first treatment). 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 NCT03178669, which also lists 1 linked publication.
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 1 Feb 2021.