Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severe

A 12-Week Multicentre, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severe - EB

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001542-19-FR

Enrollment

Unknown

Registered

2020-04-03

Start date

2020-07-22

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis bullosa simplex MedDRA version: 20.0 Level: PT Classification code 10014989 Term: Epidermolysis bullosa System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Ixekizumab Product Name: Taltz 80mg Product Code: 3400930060797 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patients 6 years or older - Laboratory confirmed diagnosis of EBS-gen sev due to KRT5 or 14 mutation - DLQI or cDLQI = 10 - Subject/caregiver agrees not to use any topical therapies other than the investigator approved Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - EBS lesions requiring oral therapy to treat an infection - Use of any diacerein containing product within 6 months prior to Visit 1 - Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit - Use of systemic steroidal therapy within 30 days prior to Visit 1 - Use of any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess whether ixekizumab every 2 weeks (Q2W) is superior to placebo at Week 12 in the treatment of patients > 6 years of age with EBS-gen sev in improving their QoL;Secondary Objective: -To assess the safety of ixekizumab treatment in EBS-gen sev treated patients -To compare the efficacy and health outcomes measures evolution between ixekizumab Q2W and placebo at Week 12 in term of severity, itch, pain and duration of dressing -To compare the efficacy and health outcomes measures evolution between ixekizumab Q2W and placebo between S12 and S20 ;Primary end point(s): proportion of patients achieving = 75% of diminution of the dermatologic QoL (DLQI and cDLQI) at week 12 compared to baseline;Timepoint(s) of evaluation of this end point: AT 12 WEEKS	—

Measure

Time frame

Main Objective: to assess whether ixekizumab every 2 weeks (Q2W) is superior to placebo at Week 12 in the treatment of patients > 6 years of age with EBS-gen sev in improving their QoL;Secondary Objective: -To assess the safety of ixekizumab treatment in EBS-gen sev treated patients -To compare the efficacy and health outcomes measures evolution between ixekizumab Q2W and placebo at Week 12 in term of severity, itch, pain and duration of dressing -To compare the efficacy and health outcomes measures evolution between ixekizumab Q2W and placebo between S12 and S20 ;Primary end point(s): proportion of patients achieving = 75% of diminution of the dermatologic QoL (DLQI and cDLQI) at week 12 compared to baseline;Timepoint(s) of evaluation of this end point: AT 12 WEEKS

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Secondary

Measure	Time frame
Secondary end point(s): - Safety and tolerability will be assessed through the description of specific events occurring during the study - Secondary efficacy and health outcomes measures - Severity of EB will be assessed using the validated score iscorEB, the static - Physician Global Assessment (sPGA) and the patient global assessment (PaGA) - Itch will be assessed using a visual analogic scale (VAS). - Pain will be assessed using a VAS - The duration of dressing will be evaluated by patients/parents on the week before visit - The QoL and the efficacy and health outcomes measures during the follow-up post-treatment period (S12-S20) will be defined as for the treatment period ;Timepoint(s) of evaluation of this end point: AT 12 WEEKS	—

Measure

Time frame

Secondary end point(s): - Safety and tolerability will be assessed through the description of specific events occurring during the study - Secondary efficacy and health outcomes measures - Severity of EB will be assessed using the validated score iscorEB, the static - Physician Global Assessment (sPGA) and the patient global assessment (PaGA) - Itch will be assessed using a visual analogic scale (VAS). - Pain will be assessed using a VAS - The duration of dressing will be evaluated by patients/parents on the week before visit - The QoL and the efficacy and health outcomes measures during the follow-up post-treatment period (S12-S20) will be defined as for the treatment period ;Timepoint(s) of evaluation of this end point: AT 12 WEEKS

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Countries

France

Contacts

Public ContactCaillon

CHU de Nice

caillon.c@chu-nice.fr0033492034589

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026