Nemolizumab for Prurigo Nodularis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prurigo NodularisNemolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if a drug called nemolizumab is still effective in treating prurigo nodularis after participants stop taking it. It will also look at the safety of the drug.

Eligible Conditions
  • Prurigo Nodularis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline, Week 16 and 24

Week 32
Incidence and Severity of Adverse Events (AEs), Including Treatment-Emergent AEs (TEAEs), Adverse Events of Special Interest (AESIs), Serious AEs (SAEs), Treatment-Related AEs, and AEs that Lead to Discontinuation
Week 24
Absolute and Percent Change from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Each Scheduled Visit
Absolute and Percent Change from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Each Scheduled Visit
Increase in (Weekly Average of the) Peak Pruritus (PP) Numeric Rating Scale (NRS) Score ≥4 Points from Baseline
Increase in Investigator Global Assessment (IGA) Score ≥2 Points From Baseline
Proportion of Participants Maintaining Investigator Global Assessment (IGA) Success, Defined as IGA Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit
Proportion of Participants With Increase in Investigator Global Assessment (IGA) >= 2 Points From Baseline at Each Scheduled Visit
Proportion of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points from Baseline at Each Scheduled Visit
Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 and Week 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Nemolizumab (30 mg)
25%Nasopharyngitis
23%Dermatitis atopic
12%Asthma
11%Upper respiratory tract infection
7%Headache
5%Sinusitis
5%Gastroenteritis
5%Folliculitis
5%Dry skin
5%Rhinitis
5%Arthralgia
5%Cough
5%Back pain
5%Abdominal pain
5%Diarrhoea
2%Blood creatine phosphokinase increased
2%Oral herpes
2%Urinary tract infection
2%Pyrexia
2%Cellulitis
2%Nausea
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03100344) in the Nemolizumab (30 mg) ARM group. Side effects include: Nasopharyngitis with 25%, Dermatitis atopic with 23%, Asthma with 12%, Upper respiratory tract infection with 11%, Headache with 7%.

Trial Design

2 Treatment Groups

Nemolizumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Nemolizumab · Has Placebo Group · Phase 3

Nemolizumab
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 16 and 24

Who is running the clinical trial?

Galderma R&DLead Sponsor
289 Previous Clinical Trials
59,584 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
1,064 Patients Enrolled for Prurigo Nodularis

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The 4-point improvement in weekly average of PP NRS score from baseline of the lead-in study Note: Lead-in study baseline is defined as baseline PP NRS score in the Phase 3 studies RD.06.SPR.
Subjects must be of childbearing potential (i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile).
You are postmenopausal, aged 50 years or older, and have no menstrual bleeding for 1 year prior to baseline.
Participants with uninterrupted dosing of nemolizumab in the LTE study RD.06.SPR.
You are 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 subject using an electronic handheld device provided for this study.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%