A prospective, multicenter long-term study to assess the safety and efficacy of Nemolizumab (CD14152) in patients with Prurigo Nodularis

ID di studio ICTRP
NCT04204616 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis (BASEC)

Titolo accademico
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (ICTRP)

Titolo pubblico
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (ICTRP)

Malattie studiate
Prurigo Nodularis (ICTRP)

Intervento studiato
Drug: Nemolizumab (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

- Participants who may benefit from study participation in the opinion of the
investigator and participated in a prior nemolizumab study for PN including: (a).
Participants who completed the treatment period in a phase 3 pivotal study
(NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were
previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c).
Participants who completed through Week 24 of the phase 3b durability study
(NCT05052983) or who exit the study due to relapse may be eligible to re-enter in
the LTE study within 28 days of exiting the durability study (selected countries/
selected sites)

- Female participants of childbearing potential (that is, fertile, following menarche
and until becoming post-menopausal unless permanently sterile) must agree either to
be strictly abstinent throughout the study and for 12 weeks after the last study
drug injection, or to use an adequate and approved method of contraception
throughout the study and for 12 weeks after the last study drug injection

- Participant willing and able to comply with all of the time commitments and
procedural requirements of the clinical study protocol, including periodic weekly
recordings by the participant using an electronic handheld device provided for this
study

- Understand and sign an informed consent form (ICF) before any investigational
procedure(s) are performed

Exclusion Criteria:

- Participants who, during their participation in a prior nemolizumab study,
experienced an adverse event (AE) which in the opinion of the investigator could
indicate that continued treatment with nemolizumab may present an unreasonable risk
for the participant

- Body weight < 30 kg

- Pregnant women (positive pregnancy test result at screening or baseline visit or
re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during
the clinical study

- Any medical or psychological condition that may put the participant at significant
risk according to the investigator's judgment, if he/she participates in the
clinical study, or may interfere with study assessments (example, poor venous access
or needle-phobia)

- Planning or expected to have a major surgical procedure during the clinical study

- Participants unwilling to refrain from using prohibited medications during the
clinical study

- History of alcohol or substance abuse within 6 months prior to the screening visit
or re-entry Week R0 visit (ICTRP)

non disponibile

Endpoint primari e secondari
Incidence of Adverse Events (AEs) by Severity (ICTRP)

Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184;Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184;Percentage of Participants with Low Disease Activity State up to Week 184;Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184;Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184;Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184;Percentage of Participants with PP NRS <2 up to Week 184;Percent Change from Baseline in PP NRS up to Week 184;Absolute Change from Baseline in PP NRS up to Week 184;Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52;Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52;Percent Change from Baseline in AP NRS up to Week 52;Absolute Change from Baseline in AP NRS up to Week 52;Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184;Percent Change from Baseline in SD NRS up to Week 184;Absolute Change from Baseline in SD NRS up to Week 184;Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184;Change from Baseline in PN-associated Pain Intensity up to Week 184;Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52;Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52;Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184;Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184;Time to Permanent Study Drug Discontinuation;Time to Rescue Therapy;Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment (ICTRP)

Data di registrazione
17.12.2019 (ICTRP)

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Galderma Research & Development, clinical.studies@galderma.com, 817-961-5000 (ICTRP)

ID secondari
2019-004294-13, RD.06.SPR.202699 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04204616 (ICTRP)