← Back to Search

Monoclonal Antibodies

Nemolizumab 30 mg 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 pre-infusion, post infusion on day 29, 57, 85, 113, 169, 225

Awards & highlights

Study Summary

This trialwill test if a new drug can help people 18+ with prurigo nodularis after 16 weeks.

Eligible Conditions

Prurigo Nodularis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-infusion, post infusion on day 29, 57, 85, 113, 169, 225

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-infusion, post infusion on day 29, 57, 85, 113, 169, 225

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-infusion, post infusion on day 29, 57, 85, 113, 169, 225 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16

Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16

Secondary outcome measures

Absolute Change from Baseline in AP NRS Through Week 24

Absolute Change from Baseline in PP NRS Through Week 24

Absolute Change from Baseline in SD NRS Through Week 24

+39 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nemolizumab 30 milligram (mg)Experimental Treatment1 Intervention

Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemolizumab 30 mg

2020

Completed Phase 3

~290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor

299 Previous Clinical Trials

60,134 Total Patients Enrolled

4 Trials studying Prurigo Nodularis

828 Patients Enrolled for Prurigo Nodularis

Frequently Asked Questions

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

Has the FDA cleared Nemolizumab 30 mg for public consumption?

"There is both clinical and anecdotal evidence supporting the safety of Nemolizumab 30 mg, so it received a score of 3."

Answered by AI

Could you please list any other previous research studies that have used Nemolizumab 30 mg?

"Currently, there are 10 clinical trials underway that are studying the effects of Nemolizumab 30 mg. Of those 10 trials, 7 are in Phase 3. Although the majority of these trials are taking place in Regensburg, Missouri, there are a total of 1161 locations around the world where these trials are being conducted."

Answered by AI

Can you tell me how many different places this trial is taking place?

"To make things more convenient for potential participants, this trial is being run in 38 different locations. Some examples of these locations include Laredo, Ann Arbor and Delray Beach."

Answered by AI

Do we have any other trials like this one that we can compare it to?

"As of now, there are 10 ongoing trials for the use of Nemolizumab 30 mg in 237 cities and 25 countries. The initial trial for this medication was conducted in 2019 by Galderma R&D. That initial study had 750 participants and reached Phase 3 approval. Since 2019, a total of 18,242 studies have been completed."

Answered by AI

Are subjects being recruited for this experiment at this time?

"This study is no longer recruiting patients. However, there are 10 other clinical trials for neurodermatitis and 10 for Nemolizumab 30 mg that are actively enrolling patients."

Answered by AI

How many people total can join this research project?

"Recruitment for this study has ended. It was initially posted on September 11th, 2020 and was last updated on October 11th, 2020. There are 10 other trials for neurodermatitis and 10 for Nemolizumab 30 mg that are still admitting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

2020. "An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04501666.