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

Ulcerative Colitis Clinical Trial

— CONDUCT  

Official title:

A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178669
• Other study ID #: CSUC-01/16
• Secondary ID: 2016-004217-26
• Status: Completed
• Phase: Phase 2
• Start date: June 21, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2021
• Source: InDex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a) 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-a 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• cobitolimod
Rectal administration
• Placebo
Solution manufactured to mimic cobitolimod

Locations

Country	Name	City	State
Czechia	1	Prague
France	2	Amiens
France	3	Caen
France	4	Clichy
France	5	Grenoble
France	6	Nice
France	7	Pierre-Bénite
France	8	Saint-Étienne
France	9	Toulouse
France	10	Vandœuvre-lès-Nancy
Germany	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
Hungary	22	Békéscsaba
Hungary	21	Budapest
Hungary	23	Debrecen
Hungary	24	Mosonmagyarovar
Hungary	25	Pécs
Poland	26	Czestochowa
Poland	27	Kraków
Poland	28	Ksawerów
Poland	33	Lódz
Poland	29	Lublin
Poland	30	Poznan
Poland	31	Sopot
Poland	32	Warszawa
Poland	32	Wloclawek
Poland	33	Wroclaw
Russian Federation	34	Cheboksary
Russian Federation	35	Ekaterinburg
Russian Federation	36	Kazan
Russian Federation	37	Kirov
Russian Federation	38	Moscow
Russian Federation	39	Novosibirsk
Russian Federation	40	Ryazan'
Russian Federation	41	Saint Petersburg
Russian Federation	42	Stavropol'
Russian Federation	43	Tver
Russian Federation	44	Ufa
Serbia	45	Belgrad
Spain	46	Ferrol
Spain	47	Fuenlabrada
Spain	48	Madrid
Spain	49	Sevilla
Spain	50	Valencia
Sweden	51	Uppsala
Ukraine	52	Chernivtsi
Ukraine	53	Dnipropetrovs'k
Ukraine	54	Ivano-Frankivs'k
Ukraine	55	Kharkiv
Ukraine	56	Kiev
Ukraine	57	Luts'k
Ukraine	58	Lviv
Ukraine	59	Odesa
Ukraine	60	Sumy
Ukraine	62	Úzhgorod
Ukraine	61	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
InDex Pharmaceuticals

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Hungary,  Poland,  Russian Federation,  Serbia,  Spain,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Week 6
Secondary	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)	Week 6
Secondary	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)	Week 6
Secondary	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)	Week 6
Secondary	Histological Remission	Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1	Week 6