E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus (SLE) |
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E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
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 |
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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 |
To compare the efficacy of 450 mg LY3361237 every 2 weeks versus placebo with respect to arthritis and/or rash remission in participants with Systemic Lupus Erythematosus (SLE) |
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E.2.2 | Secondary objectives of the trial |
To compare 450 mg LY3361237 every 2 weeks versus placebo with respect to SLE clinical signs and symptoms treatment response
To characterize the pharmacokinetics (PK) of 450 mg LY3361237 every 2 weeks in participants with SLE
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Ages 18-65 years old -Diagnosis of SLE for at least 24 weeks prior to screening - Have documentation of having a total score of 10 or more points on EULAR/ACR 2019 classification criteria for SLE (Aringer et al. 2019) before randomization (Visit 2). -Positive ANA and/or positive anti-dsDNA and/or positive anti-Sm antibody test at screening -SLEDAI-2k score of >/= 6 at screening -Clinical SLEDAI-2k score of >/= 4 at randomization -Have active arthritis and/or active rash as defined by the SLEDAI 2K at screening and at randomization.
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E.4 | Principal exclusion criteria |
Corticosteriod use: -Current oral corticosteroid doses > 20mg per day or adjusted dosage within 2 weeks prior to randomization -Received topical corticosteroids other than stable doses of Class VI or Class VII within 8 week before randomization -Received parenteral corticosteroids within 12 weeks prior to randomization or are expected to require steroids during the study
Excluded conmeds -Adjusted dose or addition of 2nd antimalarial (12 weeks) -Adjusted dose or addition of 2nd immunosuppressant (12 weeks) -Oral calcineurin inhibitor (4 weeks) -JAK inhibitor (4 weeks) -Adjusted steroid dose (2 weeks) -Cyclophosphamide or other cytotoxic agent (12 weeks)
-Biologic therapies: rituximab, ocrelizumab or other B-cell-depleting agent (24 weeks), other biologic therapies (12 weeks)
-IV Ig (24 weeks)
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants with arthritis and/or rash at baseline who achieve remission of arthritis and/or rash as defined by SLEDAI-2K at Week 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Proportion of participants who achieve SLEDAI-4 response at Week 24 - Proportion of participants who achieve SRI 4 response at Week 24 - Steady-state trough serum concentration of LY3361237 at Week 24
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 |
Czechia |
Mexico |
Poland |
Puerto Rico |
Russian Federation |
Ukraine |
United States |
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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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LVLS- Last Visit or last scheduled procedure for the last patient |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 29 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 29 |