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

InDex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: cobitolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT03178669

CSUC-01/16

2016-004217-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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213 participants in 5 patient groups, including a placebo group

Cobitolimod Dose 2x31 mg

Experimental group

Description:

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

Treatment:

Drug: cobitolimod

Cobitolimod Dose 2x125 mg

Experimental group

Description:

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

Treatment:

Drug: cobitolimod

Cobitolimod Dose 2x250 mg

Experimental group

Description:

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

Treatment:

Drug: cobitolimod

Cobitolimod Dose 4x125 mg

Experimental group

Description:

Dose 125 mg of cobitolimod, at 4 occasions

Treatment:

Drug: cobitolimod

Placebo

Placebo Comparator group

Description:

Placebo at four occasions

Treatment:

Drug: Placebo