SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2013-004599-36-DE
• Date of registration: 03/02/2014
• Prospective Registration: Yes
• Primary sponsor: sterna biologicals GmbH & Co. KG
• Public title: SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily
• Scientific title: SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE
• Date of first enrolment: 23/04/2014
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004599-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Center for Clinical Studies
• Affiliation: Universitätsklinikum Erlangen

• Name: Center for Clinical Studies
• Affiliation: Universitätsklinikum Erlangen

Key inclusion & exclusion criteria

Inclusion criteria:
? 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
Colectomy and presence of ileal pouch-anal anastomosis or ileorectal anastomosis.
Diagnosis of ulcerative proctitis.
Ileostoma.
Diagnosis of fulminant colitis.
Diagnosis of toxic megacolon.
Diagnosis of colitis indeterminata.
Diagnosis of Crohn’s disease.
Anti-TNFa treatment with adalimumab, certolizumab, etanercept, golimumab, or infliximab =4 weeks prior to screening visit [V1].
Change in systemic glucocorticoid treatment =1 weeks prior to screening visit [V1]
Change in 5-ASA therapy =1 week prior to screening visit [V1].
Start of treatment with an immunosuppressive agent =3 months prior to screening visit [V1].
Change in treatment with an immunosuppressive agent =4 weeks prior to baseline visit [V1].
Planned concomitant therapeutic administration of suppositories or foams or enema other than the IMP.
Impaired blood coagulation (Quick value <50% and/or 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 CCS Erlangen, 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Active ulcerative colitis

Intervention(s)

Product Name: SB012
Pharmaceutical Form: Enema
INN or Proposed INN: hgd40
Current Sponsor code: hgd40
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Enema
Route of administration of the placebo: Rectal use

Primary Outcome(s)

Main Objective: The primary objective of this clinical trial is to evaluate the efficacy of SB012 enema in subjects with moderate to severe active ulcerative colitis at end of treatment.

Secondary Objective: ? To evaluate the efficacy of SB012 enema four weeks after end of treatment.
? To evaluate the effects of SB012 enema on glucocorticoid consumption four weeks after end of treatment.
? To evaluate the pharmacokinetics of SB012 enema.
? To evaluate the safety and tolerability of SB012 enema.

Timepoint(s) of evaluation of this end point: At baseline visit and at Day 28 (after four weeks of treatment).

Primary end point(s): Change in Total Mayo score after 4 weeks of treatment compared to baseline value in the active treatment group (SB012) versus placebo.

Secondary Outcome(s)

Secondary end point(s): ? Change in Total Mayo score 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.
? Change in Endoscopic Mayo score 4 and 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.
? Change in systemic glucocorticoid consumption (measured as DDD) 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.
? Number of treatment-emergent AEs and SAEs in the active treatment group (SB012) versus placebo.
? In subjects with hgd40 plasma levels equal to or above LLOQ: mean hgd40 plasma concentrations per time point.
? Changes in systemic biomarker plasma levels 4 and 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.
? Change in GATA-3 mRNA expression 4 and 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.
? Change in Riley score 4 and 8 weeks after start of treatment compared to baseline value in the active treatment group (SB012) versus placebo.

Timepoint(s) of evaluation of this end point: At baseline visit, at Day 28 (after four weeks of treatment) and at Day 56 (after four weeks of treatment and four weeks of follow-up).

Secondary ID(s)

SB012/01/2013

Source(s) of Monetary Support

sterna biologicals GmbH & Co. KG

Ethics review

Status: Approved
Approval date:
Contact: