E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active ulcerative colitis |
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E.1.1.1 | Medical condition in easily understood language |
Active ulcerative colitis |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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-TNFα 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline visit and at Day 28 (after four weeks of treatment). |
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E.5.2 | 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. |
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E.5.2.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |