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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 up to 192 weeks
Awards & highlights

Study Summary

This trial will study the long-term safety of the drug nemolizumab in people with a skin condition called prurigo nodularis.

Who is the study for?
This trial is for individuals with Prurigo Nodularis who've been in previous nemolizumab studies. They must be able to follow the study's procedures, including weekly electronic check-ins. Women of childbearing age should avoid pregnancy or use contraception during and for 12 weeks post-trial.Check my eligibility
What is being tested?
The focus of this study is on the long-term safety of a drug called nemolizumab (CD14152) for those suffering from Prurigo Nodularis, a skin condition that causes itchy nodules.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to nemolizumab as part of assessing its long-term safety profile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 192 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 192 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs) by Severity
Secondary outcome measures
Absolute Change from Baseline in AP NRS up to Week 52
Absolute Change from Baseline in PP NRS up to Week 184
Absolute Change from Baseline in SD NRS up to Week 184
+22 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
28%
Dermatitis atopic
23%
Nasopharyngitis
18%
Asthma
9%
Headache
7%
Gastroenteritis
7%
Upper respiratory tract infection
5%
Oral herpes
5%
Pyrexia
4%
Cough
4%
Back pain
2%
Diarrhoea
2%
Rhinitis
2%
Urinary tract infection
2%
Blood creatine phosphokinase increased
2%
Nausea
2%
Septic shock
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (90 mg)
Nemolizumab (10 mg)
Nemolizumab (30 mg)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: NemolizumabExperimental Treatment1 Intervention
Participants weighing less than (<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.
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
298 Previous Clinical Trials
59,868 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
664 Patients Enrolled for Prurigo Nodularis

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04204616 — Phase 3
Prurigo Nodularis Research Study Groups: Nemolizumab
Prurigo Nodularis Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT04204616 — Phase 3
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04204616 — Phase 3

Frequently Asked Questions

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

Is this research being conducted at various sites across the nation?

"There are 59 sites across the country that are currently recruiting patients for this study. A few notable locations include Springville, Chicago and Los Angeles. The study team suggests that patients enroll at the location closest to them to minimize travel."

Answered by AI

What is the current research on Nemolizumab's effects?

"Currently, there are 10 ongoing clinical trials studying the effects of Nemolizumab with 7 of those trials in Phase 3. Most of the research being conducted on Nemolizumab is happening in Regensburg, Missouri, but there are a total of 1161 clinical trial sites worldwide."

Answered by AI

How can somebody sign up for this research project?

"No, this study is not currently recruiting patients for clinical trials. Although the study was originally posted on December 15th 2020, the last edit was made on October 19th 2022. There are, however, 20 other clinical trials that are currently enrolling patients."

Answered by AI

Does this trial explore new territory for medical science?

"Nemolizumab has been the focus of 10 clinical trials since 2019. These global studies, sponsored by Galderma R&D, have taken place in 25 countries and 237 cities. The first trial completed its Phase 3 drug approval stage in 2019 and involved 750 participants. 5 additional studies have been conducted since then."

Answered by AI

Has the FDA sanctioned Nemolizumab for general use?

"Nemolizumab is estimated to be a safe medication according to our team's 3-point scale because it has reached Phase 3 in clinical trials. This signifies that, in addition to supporting data, there are multiple rounds of data indicating its safety."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Galderma Investigational Site
Recent research and studies
clinicaltrials.govStudy
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
2021. "A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04204616.
All > Prurigo Nodularis > Atopic Dermatitis
~189 spots leftby Oct 2026
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