E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Pre-eclampsia is a combination of proteinuria and hypertension during pregnancy. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027620 |
E.1.2 | Term | Mild or unspecified pre-eclampsia |
E.1.2 | System Organ Class | 100000004868 |
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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 |
Part 1:
To assess the maternal, fetal, and neonatal safety and tolerability of RLX030 at three doses and placebo when administered intravenously as infusion for 72 hours to women with pre-eclampsia.
To investigate the Pharmacokinetics (PK) and development of anti-drug antibodies (ADAs) (maternal/neonatal) after RLX030 and placebo when administered intravenously as infusion for 72 hours to women with pre-eclampsia.
Part 2:
To assess the efficacy of RLX030 at the selected dose from Part 1 vs. placebo when administered intravenously as infusion for 72 hours on prolonging pregnancy in days (24 hours) in women with pre-eclampsia.
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E.2.2 | Secondary objectives of the trial |
Part 1:
To assess the effects of RLX030 at three doses and placebo when administered intravenously as infusion for 72 hours on prolonging of pregnancy in days (24 hours) in women with pre-eclampsia.
Part 2:
To assess the effects of RLX030 versus placebo when administered intravenously as infusion for 72 hours in women with pre-eclampsia.
To investigate the Pharmacokinetics (PK) ,and development of anti-drug antibodies (ADAs) (maternal/neonatal) after RLX030 and placebo when administered intravenously as infusion for 72 hours to women with pre eclampsia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women that are 28- 33 weeks (+4 days) pregnant with a diagnosis of pre- eclampsia or superimposed pre-eclampsia requiring hospitalization
- Fetus deemed in reasonably good health
Other protocol-defined inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
- Severe hypertension and /or those receiving anti-hypertensive treatment at time of enrollment
- Severe headaches, visual changes, or altered mentation
- Upper abdominal pain, nausea, or vomiting
- Low blood platelet count
- Diagnosis of a seizure disorder that requires chronic medication
- Those receiving active anti-coagulation therapy
- Pre-gestational diabetes (Type 1 or Type 2)
- Allergy to magnesium sulfate or steroids
- Known major fetal anomaly
- Multifetal gestation
Other protocol-defined exclusion criteria may apply
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E.5 End points |
E.5.1 | Primary end point(s) |
Part 1: Safety and tolerability
Part 2: Days to delivery
Safety and tolerability will be assessed by adverse events, blood pressure and renal function of the mother, blood flow, heart rate, gestational age and health outcome of the fetus.
Days of pregnancy will be calculated as the time between start of dosing and time of decision for delivery of birth in hours divided by 24.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Prior to delivery until 4-6 weeks post partum |
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E.5.2 | Secondary end point(s) |
1. Part 1: Days to delivery
Part 2: Safety and tolerability
Measure as for the primary end point above
2. Blood concentrations of RLX030
3. Blood samples for measurement of antibodies to RLX030 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Prior to delivery until 4-6 weeks post partum
2. Baseline, 2, 6, 24, 48, 72, 76, 80 and 90 hours after initiation of infusion
3. Baseline and 7 days post-partum in both mother and infant |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
France |
Germany |
Italy |
South Africa |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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End of trial is the last visit of the last subject in 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |