← Back to Search

Monoclonal Antibodies

Nemolizumab for Prurigo Nodularis

Phase 3
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16 and 24
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
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
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 and Week 24
+4 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
33%
Nasopharyngitis
20%
Dermatitis atopic
13%
Headache
7%
Nausea
7%
Sinusitis
7%
Upper respiratory tract infection
5%
Diarrhoea
5%
Urinary tract infection
4%
Blood creatine phosphokinase increased
4%
Oral herpes
4%
Asthma
2%
Back pain
2%
Arthralgia
2%
Cardio-respiratory arrest
2%
Pyrexia
2%
Cough
2%
Abdominal pain
2%
Staphylococcal sepsis
2%
Asthenia
2%
Post-traumatic amnestic disorder
2%
Pneumonia aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (10 mg)
Nemolizumab (90 mg)
Nemolizumab (30 mg)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NemolizumabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2021
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
299 Previous Clinical Trials
60,386 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
1,080 Patients Enrolled for Prurigo Nodularis

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05052983 — Phase 3
Prurigo Nodularis Research Study Groups: Nemolizumab, Placebo
Prurigo Nodularis Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT05052983 — Phase 3
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052983 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have a broad reach in North America?

"Right now, this research is enrolling at 4 sites. They are in Morgantown, Irvine, Bellaire and several other places. If you decide to participate, try to choose the location nearest to you in order to limit travel."

Answered by AI

Can new patients join this clinical trial?

"That is correct. The clinical trial in question is recruiting patients, as of 10/14/2022. This particular trial was originally posted on 1/23/2022 and is looking for 60 total participants from 4 different locations."

Answered by AI

Has there been any research like this before?

"There are 10 ongoing Nemolizumab trials in 25 countries and 237 cities. The first study was completed in 2019 and was sponsored by Galderma R&D. It included 750 participants and completed Phase 3 drug approval. A total of 18242 studies have been completed since then."

Answered by AI

Could you tell me about other similar research studies that have used Nemolizumab?

"Nemolizumab was first studied in 2019 at Galderma Investigational Site 6066. There have been 18242 completed trials since then. Currently, there are 10 active trials, a majority of which are based in Morgantown, West virginia."

Answered by AI

Does the FDA sanction Nemolizumab for public use?

"Nemolizumab is a Phase 3 drug, meaning that it has undergone some efficacy testing as well as multiple rounds of safety testing. Therefore, our team rates its safety as a 3."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
2022. "A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05052983.
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top