Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02129439
• Date of registration: 30/04/2014
• Prospective Registration: No
• Primary sponsor: Sterna Biologicals GmbH & Co. KG
• Public title: Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients SECURE
• Scientific title: SB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered OD
• Date of first enrolment: April 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02129439
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany

Contacts

• Name: Markus F. Neurath, Prof. Dr.
• Affiliation: Department of Medicine 1 - Gastroenterology, Pneumology and Endocrinology, University Clinic Erlangen, Germany

Key inclusion & exclusion 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-TNFa 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: SB012

Primary Outcome(s)

Efficacy: Total Mayo score (4 weeks comparison) [Time Frame: Baseline (Visit 2) to day 28 (Visit 7) (28 days)]

Secondary Outcome(s)

Efficacy: Endoscopic Mayo score (4 and 8 weeks comparison) [Time Frame: Baseline (Visit 2) to Visit 7 and Visit 10 (28 and 56 days)]

Safety: Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) [Time Frame: Visit 1 (Screening) to Visit 10 (End of Study - 56 days) or Visit X (Early Study Termination)]

Efficacy: Total Mayo score (8 weeks comparison) [Time Frame: Baseline (Visit 2) to End-of-Study Visit10 (56 days)]

Efficacy/Pharmacodynamics: Glucocorticoid consumption [Time Frame: Baseline (Visit 2) to day 56 End of Study Visit 10 (56 days)]

Secondary ID(s)

SB012/01/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors