Clinical trial NCT02129439 (phase 1/phase 2, status: completed)
Conditions: colitis, ulcerative
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: sb012, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

        The trial population consists of adult subjects of both sexes with active ulcerative
        colitis aged 18 to 75 years.

        The main inclusion criteria comprise:

          -  Fully capable to give informed consent.

          -  Mentally able to understand the nature, significance, implications and risks of the
             clinical trial and to follow instructions of the trial staff.

          -  Written informed consent

          -  Clinical Mayo Score of ≥3

          -  Total Mayo Score of ≥6

          -  Endoscopic Mayo score ≥2 in the sigmoid

          -  Body mass index ≥18.0 to ≤29.0kg/m2 and body weight ≥50 to ≤100kg

          -  Negative urine pregnancy test (female subject only)

          -  Using two methods of contraception

        Exclusion Criteria:

          -  Colectomy and presence of ileal pouch-anal anastomosis or ileorectal anastomosis

          -  Diagnosis of ulcerative proctitis, fulminant colitis, toxic megacolon, of colitis
             indeterminata or Crohn's disease

          -  Ileostoma

          -  Anti-TNFα treatment with adalimumab, certolizumab, etanercept, golimumab, or
             infliximab ≤4 weeks prior to screening visit.

          -  Change in systemic glucocorticoid treatment ≤1 weeks prior to screening visit

          -  Change in 5-Aminosalicylic Acid (ASA) therapy ≤1 week prior to screening visit

          -  Start of treatment with an immunosuppressive agent ≤3 months prior to screening visit

          -  Change in treatment with an immunosuppressive agent ≤4 weeks prior to baseline visit

          -  Planned concomitant therapeutic administration of suppositories or foams or enema
             other than the IMP.

          -  Impaired blood coagulation (Quick value <50% and/or partial thromboplastin time (PTT)
             >55sec and/or platelet count <50.000/μl.)

          -  Signs of renal insufficiency

          -  Signs of hepatic insufficiency.

          -  Current treatment with drugs of high hepatotoxic potential.

          -  Evidence of recent alcohol abuse.

          -  Acute or chronic heart failure with NYHA functional class III or IV.

          -  Known active tuberculosis.

          -  Known acute serious infections or sepsis.

          -  Known current malignant disease.

          -  Positive blood test against HBs antigen, anti-HBc antibodies, anti-HCV antibodies or
             anti-HIV-1/2 antibodies.

          -  Known opportunistic infections including invasive fungal infections.

          -  Known hypersensitivity to the IMP or any of their formulation ingredients.

          -  Any condition that is thought to reduce the compliance to cooperate with the trial
             procedures.

          -  Employee of the department of the investigator, of the Center for Clinical Studies
             (CCS) or of the sponsor.

          -  Prior participation in this clinical trial.

          -  Participation in an interventional clinical trial within the last three months (six
             months in case of a biological IMP) or be under the exclusion period from another
             clinical trial.

          -  Known or planned absence that may collide with the clinical trial visit schedule.