Table 4.
Multiple sclerosis PIP-requested clinical studies.
| No. | Compound and PIP No. | Abbreviated Study Description | Until |
|---|---|---|---|
| 1 | Alemtuzumab EMEA-001072-PIP01-10 |
R PG S&E T study compared with an appropriate comparator in 10 to <18 year olds with R/R MS w/ prior DMT | 2018 |
| 2 | MAB (LY2127399) EMEA-000802-PIP01-09 |
MC OL R AC (IFβ1a) study on T, PK, S&E in children w/ R/R MS | 2023 |
| 3 | Daclizumab EMEA-001349-PIP01-12-M01 |
OL R AC S&E T study in 10 to <18 year olds w/ R/R MS followed by a 24-month extension study | 2019 |
| 4 | Dimethyl fumarate EMEA-000832-PIP01-10-M02 |
OL R MC MD AC PG S&E study in 10 to <18 year olds w/ R/R MS | 2016 |
| 5 | Fingolimod EMEA-000087-PIP01-07-M03 |
DB R MC MD AC (IFβ1) PG PK S&E study in 10 to <18 year olds, followed by a long-term extension study | 2019 |
| 6 | Laquinimod EMEA-000972-PIP01-10-M04 |
OL SA PK S T single oral dose study in 10 to <18 year olds w/ R/R MS R MC PG AC T S&E AC trial in 10 to <18 year olds w/ R/R MS; blinded MRI assessment |
2018 |
| 7 | Natalizumab EMEA-001095-PIP02-12 |
OL RD PK S study in 10 to <18 year olds w/ R/R MS Meta-analysis of natalizumab S&E in pediatric patients with MS |
2015 |
| 8 | Ocrelizumab EMEA-000310-PIP03-10-M01 |
OL PG SD T PK S&E of three ascending doses in 10 to <18 year olds w/ R/R MS R OL AC (IFβ1a) PG S&E study in 10 to <18 year olds w/ R/R MS |
2023 |
| 9 | Ozanimod EMEA-001710-PIP02-14 |
DB DD R AC S&E trial compared with IFβ1a in 10 to <18 year olds w/ R/R MS Development of a population PK/PD model to support the choice of dose in the S&E study in 10 to <18 year olds w/ R/R MS |
2022 |
| 10 | Pegylated IFβ EMEA-001129-PIP01-11-M1 |
OL R AC S&E trial in 10 to <18 year olds w/ R/R MS | 2021 |
| 11 | Ponesimod EMEA-000798-PIP01-09 |
MC R OL AC (IFβ1a) PG PK PD S&E T study in 10 to <18 year olds w/ R/R MS | 2022 |
| 12 | Siponimod EMEA-000716-PIP01-09-M01 |
OL R MC MD AC PG S&E study in 10 to < 18 year olds w/ R/R MS | 2024 |
| 13 | Teriflunomide EMEA-001094-PIP01-10-M02 |
DB R MC PC PG PK S&E T trial in 10 to <18 year olds w/ R/R MS, followed by a long-term extension | 2020 |
All PIP decisions can be downloaded by googling the respective PIP number (given in column 2).
AC, active controlled; DD, double dummy; DMT, disease-modifying treatment; MAB, monoclonal antibody; IFβ, interferon β; MC, multicenter; MS, multiple sclerosis; OL, open label; PD, pharmacodynamics; PIP, European Union pediatric investigation plan; PK, pharmacokinetics; PG, parallel group; R, randomized; R/R, relapsing/remitting; S, safety; S&E, safety and efficacy; T, tolerability; w/, with.