E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) |
|
E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus (SLE) |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 |
Determine the long-term safety and tolerability of atacicept in SLE subjects. |
|
E.2.2 | Secondary objectives of the trial |
1. Evaluate the effect of atacicept on changes in disease activity over time.
2. Evaluate the effect of atacicept in reducing corticosteroid (CS) usage.
3. Evaluate the immunogenicity, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of atacicept.
4. Evaluate the effect of atacicept on patient-reported outcomes (PROs).
5. Identify potential associations of genetic variations and gene expression with atacicept response, efficacy, and safety. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetic study; Objective see E.2.2 |
|
E.3 | Principal inclusion criteria |
- Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial).
- Women of childbearing potential (WOCBP) who have a negative pregnancy test
- Other protocol defined inclusion criteria may apply |
|
E.4 | Principal exclusion criteria |
- Active neurological symptoms of SLE that are deemed severe or progressive
- Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
- Pregnancy
- Other protocol defined exclusion criteria may apply |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Number of subjects reporting at least one SAE during the treatment period.
- Number of subjects prematurely discontinuing the treatment due to AE. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Continuous throughout treatment period up to week 96 |
|
E.5.2 | Secondary end point(s) |
- Change from Baseline in SLICC/ACR Damage Index organ damage scores at Week 96
- Change from Baseline in disease activity as measured by BILAG at Week 96
- Change from Baseline in disease activity as measured by SLEDAI-2K at Week 96
- Change from Baseline in disease activity as measured by SRI-50 at Week 96
- Change from Baseline in disease activity as measured by PGA at Week 96
- Change from Baseline in SRI (a disease activity composite index) response at Week 96
- Change from Baseline in BICLA (a disease activity composite index) response at Week 96
- Change from Baseline in prednisone-equivalent CS dose at Week 96
- Change from Baseline in SF-36 at Week 96
- Change from Baseline in LupusQoL at Week 96
- Change from Baseline in PGIC at Week 96
- Change from Baseline in EQ-5D at Week 96
- Change from Baseline in FACIT-Fatigue at Week 96
- Number of subjects with AEs
- C-SSRS score |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker and Health resource utilization |
|
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 | No |
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 | No |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Argentina |
Brazil |
Bulgaria |
Chile |
Czech Republic |
Germany |
Italy |
Korea, Republic of |
Mexico |
Peru |
Philippines |
Poland |
Russian Federation |
South Africa |
Spain |
Ukraine |
United Kingdom |
United States |
|
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
|
When final database lock occurs (according to protocol) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |