Table 1.
Open in new tab

Paediatric clinical trial status for advanced drugs with EMA paediatric investigation plans

Drug nameMode of actionDiseaseYear of adult indication approval* or expected date of completion of ongoing Phase 3 trialsYear of paediatric indication approval* or expected date of completion of ongoing Phase 3 trialsPIP completion dateDelay in paediatric approval
Approved for both adult and paediatric CD/UC indications
InfliximabAnti-TNFαCD/UCApproved for adult CD/UC in 1998/2005Approved for paediatric CD/UC in 2006/2011Complete8 years for CD; 6 years for UC
AdalimumabAnti-TNFαCD/UCApproved for adult CD/UC in 2007/2013Approved for paediatric CD/UC in 2014/2021Complete7 years for CD; 8 years for UC
Approved for adult CD/UC with ongoing paediatric trials/approval pending
GolimumabAnti-TNFαUCApproved for CD in 2013Paediatric UC primary completion date Q4 20212024At least 9 years
VedolizumabAnti-a4-bb7 integrinCD/UCApproved for CD/UC in 2014Paediatric CD/UC primary completion date Q2 20242024At least 10 years
UstekinumabAnti-IL-12/23CD/UCApproval for CD/UC in 2016Paediatric CD and UC: primary completion dates Q3 20252025At least 5 years
TofacitinibPan-JAK inhibitorUCApproved for UC in 2018Paediatric UC primary completion date Q3 20262026At least 8 years
Drugs with ongoing adult and paediatric CD/UC trials
MirikizumabAnti-IL-23CD/UCPrimary completion of CD/UC trials expected Q4 2023/Q3 2025**Paediatric UC primary completion date Q3 20272027Unknown
Drugs with adult ongoing CD/UC trials and approved PIP for CD/UC but no paediatric trials registered
EtrolizumabAnti a4-b7/aE-b7 integrinCD/UCPrimary completion of CD trials expected Q3 2021; inconsistent results for UCNo registered paediatric trials2024Unknown
EtrasimodS1P1,4,5 modulatorCD/UCPrimary completion date of CD/UC† trials expected Q4 2021No registered paediatric trials†2025Unknown
FilgotinibJAK1 inhibitorCD/UCFiled a request to EMA for marketing authorization in 2020 for UC
Primary completion date for CD expected Q4 2022		No registered paediatric trials2026Unknown
GuselkumabAnti-IL-23CDPrimary completion of CD/UC trials expected Q2 2022No registered paediatric trials2026Unknown
OzanimodS1P receptor agonistUCPrimary completion date of CD‡/UC expected 2023/2022No registered paediatric trials‡2026Unknown
RisankizumabAnti-IL-23CD/UCPrimary endpoint met in Phase 3 trials in CD
Primary completion of UC trials expected Q3 2022†		No registered paediatric trials†2026Unknown
BrazikumabAnti-IL-23CD/UCPrimary completion of CD trial expected Q1 2027No registered paediatric trials§2030Unknown
UpadacitinibJAK1 inhibitorCD/UCPrimary completion of CD/UC† trials Q3 2021/Q1 2021No registered paediatric trials†2028Unknown
TD-1473Pan-JAK inhibitorUCPrimary complete of UC trials expected Q2 2025; CD phase 2 trial ongoingNo registered paediatric trials2030Unknown
RavagalimabAnti-CD40UCPhase 2 trial primary completion date Q4 2021No registered paediatric trials2034Unknown
Drugs with adult approval and/or ongoing CD/UC trials but with no PIP for CD/UC
CertolizumabAnti-TNFCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials. Previous paediatric CD trials terminated2008Unknown
NatalizumabSelective adhesion molecule inhibitorCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials2008Unknown
Drug nameMode of actionDiseaseYear of adult indication approval* or expected date of completion of ongoing Phase 3 trialsYear of paediatric indication approval* or expected date of completion of ongoing Phase 3 trialsPIP completion dateDelay in paediatric approval
Approved for both adult and paediatric CD/UC indications
InfliximabAnti-TNFαCD/UCApproved for adult CD/UC in 1998/2005Approved for paediatric CD/UC in 2006/2011Complete8 years for CD; 6 years for UC
AdalimumabAnti-TNFαCD/UCApproved for adult CD/UC in 2007/2013Approved for paediatric CD/UC in 2014/2021Complete7 years for CD; 8 years for UC
Approved for adult CD/UC with ongoing paediatric trials/approval pending
GolimumabAnti-TNFαUCApproved for CD in 2013Paediatric UC primary completion date Q4 20212024At least 9 years
VedolizumabAnti-a4-bb7 integrinCD/UCApproved for CD/UC in 2014Paediatric CD/UC primary completion date Q2 20242024At least 10 years
UstekinumabAnti-IL-12/23CD/UCApproval for CD/UC in 2016Paediatric CD and UC: primary completion dates Q3 20252025At least 5 years
TofacitinibPan-JAK inhibitorUCApproved for UC in 2018Paediatric UC primary completion date Q3 20262026At least 8 years
Drugs with ongoing adult and paediatric CD/UC trials
MirikizumabAnti-IL-23CD/UCPrimary completion of CD/UC trials expected Q4 2023/Q3 2025**Paediatric UC primary completion date Q3 20272027Unknown
Drugs with adult ongoing CD/UC trials and approved PIP for CD/UC but no paediatric trials registered
EtrolizumabAnti a4-b7/aE-b7 integrinCD/UCPrimary completion of CD trials expected Q3 2021; inconsistent results for UCNo registered paediatric trials2024Unknown
EtrasimodS1P1,4,5 modulatorCD/UCPrimary completion date of CD/UC† trials expected Q4 2021No registered paediatric trials†2025Unknown
FilgotinibJAK1 inhibitorCD/UCFiled a request to EMA for marketing authorization in 2020 for UC
Primary completion date for CD expected Q4 2022		No registered paediatric trials2026Unknown
GuselkumabAnti-IL-23CDPrimary completion of CD/UC trials expected Q2 2022No registered paediatric trials2026Unknown
OzanimodS1P receptor agonistUCPrimary completion date of CD‡/UC expected 2023/2022No registered paediatric trials‡2026Unknown
RisankizumabAnti-IL-23CD/UCPrimary endpoint met in Phase 3 trials in CD
Primary completion of UC trials expected Q3 2022†		No registered paediatric trials†2026Unknown
BrazikumabAnti-IL-23CD/UCPrimary completion of CD trial expected Q1 2027No registered paediatric trials§2030Unknown
UpadacitinibJAK1 inhibitorCD/UCPrimary completion of CD/UC† trials Q3 2021/Q1 2021No registered paediatric trials†2028Unknown
TD-1473Pan-JAK inhibitorUCPrimary complete of UC trials expected Q2 2025; CD phase 2 trial ongoingNo registered paediatric trials2030Unknown
RavagalimabAnti-CD40UCPhase 2 trial primary completion date Q4 2021No registered paediatric trials2034Unknown
Drugs with adult approval and/or ongoing CD/UC trials but with no PIP for CD/UC
CertolizumabAnti-TNFCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials. Previous paediatric CD trials terminated2008Unknown
NatalizumabSelective adhesion molecule inhibitorCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials2008Unknown

Primary completion dates of trials collated from clinicaltrials.gov, December 2021.

*Year of approval is for either FDA or EMA marketing authorization.

**Patients 15–80 years old are eligible for inclusion in mirikizumab Crohn’s disease trials.

†Patients 16–80 years old are eligible for inclusion in UC trials for etrasimod, risankizumab and upadacitinib.

‡Patients 12–75 years old are eligible for inclusion in CD trials for ozanimod.

¶The FDA does not currently publish initial paediatric study plans [iPSPs]. Certolizumab and natalizumab do not have EMA approval for treating either adult CD or UC.

CD, Crohn’s disease; CD40, cluster of differentiation 40; EMA, European Medicines Agency; IL, interleukin; JAK, Janus kinase; PIP, paediatric investigation plan; S1P1,4,5, sphingosine 1-phosphate receptor 1,4,5; UC, ulcerative colitis.

Table 1.
Open in new tab

Paediatric clinical trial status for advanced drugs with EMA paediatric investigation plans

Drug nameMode of actionDiseaseYear of adult indication approval* or expected date of completion of ongoing Phase 3 trialsYear of paediatric indication approval* or expected date of completion of ongoing Phase 3 trialsPIP completion dateDelay in paediatric approval
Approved for both adult and paediatric CD/UC indications
InfliximabAnti-TNFαCD/UCApproved for adult CD/UC in 1998/2005Approved for paediatric CD/UC in 2006/2011Complete8 years for CD; 6 years for UC
AdalimumabAnti-TNFαCD/UCApproved for adult CD/UC in 2007/2013Approved for paediatric CD/UC in 2014/2021Complete7 years for CD; 8 years for UC
Approved for adult CD/UC with ongoing paediatric trials/approval pending
GolimumabAnti-TNFαUCApproved for CD in 2013Paediatric UC primary completion date Q4 20212024At least 9 years
VedolizumabAnti-a4-bb7 integrinCD/UCApproved for CD/UC in 2014Paediatric CD/UC primary completion date Q2 20242024At least 10 years
UstekinumabAnti-IL-12/23CD/UCApproval for CD/UC in 2016Paediatric CD and UC: primary completion dates Q3 20252025At least 5 years
TofacitinibPan-JAK inhibitorUCApproved for UC in 2018Paediatric UC primary completion date Q3 20262026At least 8 years
Drugs with ongoing adult and paediatric CD/UC trials
MirikizumabAnti-IL-23CD/UCPrimary completion of CD/UC trials expected Q4 2023/Q3 2025**Paediatric UC primary completion date Q3 20272027Unknown
Drugs with adult ongoing CD/UC trials and approved PIP for CD/UC but no paediatric trials registered
EtrolizumabAnti a4-b7/aE-b7 integrinCD/UCPrimary completion of CD trials expected Q3 2021; inconsistent results for UCNo registered paediatric trials2024Unknown
EtrasimodS1P1,4,5 modulatorCD/UCPrimary completion date of CD/UC† trials expected Q4 2021No registered paediatric trials†2025Unknown
FilgotinibJAK1 inhibitorCD/UCFiled a request to EMA for marketing authorization in 2020 for UC
Primary completion date for CD expected Q4 2022		No registered paediatric trials2026Unknown
GuselkumabAnti-IL-23CDPrimary completion of CD/UC trials expected Q2 2022No registered paediatric trials2026Unknown
OzanimodS1P receptor agonistUCPrimary completion date of CD‡/UC expected 2023/2022No registered paediatric trials‡2026Unknown
RisankizumabAnti-IL-23CD/UCPrimary endpoint met in Phase 3 trials in CD
Primary completion of UC trials expected Q3 2022†		No registered paediatric trials†2026Unknown
BrazikumabAnti-IL-23CD/UCPrimary completion of CD trial expected Q1 2027No registered paediatric trials§2030Unknown
UpadacitinibJAK1 inhibitorCD/UCPrimary completion of CD/UC† trials Q3 2021/Q1 2021No registered paediatric trials†2028Unknown
TD-1473Pan-JAK inhibitorUCPrimary complete of UC trials expected Q2 2025; CD phase 2 trial ongoingNo registered paediatric trials2030Unknown
RavagalimabAnti-CD40UCPhase 2 trial primary completion date Q4 2021No registered paediatric trials2034Unknown
Drugs with adult approval and/or ongoing CD/UC trials but with no PIP for CD/UC
CertolizumabAnti-TNFCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials. Previous paediatric CD trials terminated2008Unknown
NatalizumabSelective adhesion molecule inhibitorCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials2008Unknown
Drug nameMode of actionDiseaseYear of adult indication approval* or expected date of completion of ongoing Phase 3 trialsYear of paediatric indication approval* or expected date of completion of ongoing Phase 3 trialsPIP completion dateDelay in paediatric approval
Approved for both adult and paediatric CD/UC indications
InfliximabAnti-TNFαCD/UCApproved for adult CD/UC in 1998/2005Approved for paediatric CD/UC in 2006/2011Complete8 years for CD; 6 years for UC
AdalimumabAnti-TNFαCD/UCApproved for adult CD/UC in 2007/2013Approved for paediatric CD/UC in 2014/2021Complete7 years for CD; 8 years for UC
Approved for adult CD/UC with ongoing paediatric trials/approval pending
GolimumabAnti-TNFαUCApproved for CD in 2013Paediatric UC primary completion date Q4 20212024At least 9 years
VedolizumabAnti-a4-bb7 integrinCD/UCApproved for CD/UC in 2014Paediatric CD/UC primary completion date Q2 20242024At least 10 years
UstekinumabAnti-IL-12/23CD/UCApproval for CD/UC in 2016Paediatric CD and UC: primary completion dates Q3 20252025At least 5 years
TofacitinibPan-JAK inhibitorUCApproved for UC in 2018Paediatric UC primary completion date Q3 20262026At least 8 years
Drugs with ongoing adult and paediatric CD/UC trials
MirikizumabAnti-IL-23CD/UCPrimary completion of CD/UC trials expected Q4 2023/Q3 2025**Paediatric UC primary completion date Q3 20272027Unknown
Drugs with adult ongoing CD/UC trials and approved PIP for CD/UC but no paediatric trials registered
EtrolizumabAnti a4-b7/aE-b7 integrinCD/UCPrimary completion of CD trials expected Q3 2021; inconsistent results for UCNo registered paediatric trials2024Unknown
EtrasimodS1P1,4,5 modulatorCD/UCPrimary completion date of CD/UC† trials expected Q4 2021No registered paediatric trials†2025Unknown
FilgotinibJAK1 inhibitorCD/UCFiled a request to EMA for marketing authorization in 2020 for UC
Primary completion date for CD expected Q4 2022		No registered paediatric trials2026Unknown
GuselkumabAnti-IL-23CDPrimary completion of CD/UC trials expected Q2 2022No registered paediatric trials2026Unknown
OzanimodS1P receptor agonistUCPrimary completion date of CD‡/UC expected 2023/2022No registered paediatric trials‡2026Unknown
RisankizumabAnti-IL-23CD/UCPrimary endpoint met in Phase 3 trials in CD
Primary completion of UC trials expected Q3 2022†		No registered paediatric trials†2026Unknown
BrazikumabAnti-IL-23CD/UCPrimary completion of CD trial expected Q1 2027No registered paediatric trials§2030Unknown
UpadacitinibJAK1 inhibitorCD/UCPrimary completion of CD/UC† trials Q3 2021/Q1 2021No registered paediatric trials†2028Unknown
TD-1473Pan-JAK inhibitorUCPrimary complete of UC trials expected Q2 2025; CD phase 2 trial ongoingNo registered paediatric trials2030Unknown
RavagalimabAnti-CD40UCPhase 2 trial primary completion date Q4 2021No registered paediatric trials2034Unknown
Drugs with adult approval and/or ongoing CD/UC trials but with no PIP for CD/UC
CertolizumabAnti-TNFCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials. Previous paediatric CD trials terminated2008Unknown
NatalizumabSelective adhesion molecule inhibitorCDApproved for use in adults with CD in the USA¶No ongoing registered paediatric trials2008Unknown

Primary completion dates of trials collated from clinicaltrials.gov, December 2021.

*Year of approval is for either FDA or EMA marketing authorization.

**Patients 15–80 years old are eligible for inclusion in mirikizumab Crohn’s disease trials.

†Patients 16–80 years old are eligible for inclusion in UC trials for etrasimod, risankizumab and upadacitinib.

‡Patients 12–75 years old are eligible for inclusion in CD trials for ozanimod.

¶The FDA does not currently publish initial paediatric study plans [iPSPs]. Certolizumab and natalizumab do not have EMA approval for treating either adult CD or UC.

CD, Crohn’s disease; CD40, cluster of differentiation 40; EMA, European Medicines Agency; IL, interleukin; JAK, Janus kinase; PIP, paediatric investigation plan; S1P1,4,5, sphingosine 1-phosphate receptor 1,4,5; UC, ulcerative colitis.

Close
This Feature Is Available To Subscribers Only

Sign In or Create an Account

Close

This PDF is available to Subscribers Only

View Article Abstract & Purchase Options

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

Close