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Unknown

INCB054707 for Prurigo Nodularis

Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1
Clinical diagnosis of PN for at least 3 months before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 48
Awards & highlights

Study Summary

This trial will study whether a new medication is effective and safe for treating prurigo nodularis, a skin condition.

Who is the study for?
This trial is for people with a skin condition called prurigo nodularis, who have at least 20 itchy bumps on two or more body areas and haven't found relief with other treatments. They should not be pregnant or planning to become so, and must have had the diagnosis for over three months.Check my eligibility
What is being tested?
The study tests INCB054707 against a placebo over 16 weeks to see if it's effective and safe in treating prurigo nodularis. After this phase, there's an additional 24-week period where all participants receive the actual drug without knowing if they initially received the drug or placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the medication application site, general discomforts like headaches or nausea, potential infection risks due to immune system changes, and possibly others as determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have more than 20 itchy spots on at least 2 different parts of my body.
Select...
I have been diagnosed with peripheral neuropathy for at least 3 months.
Select...
My previous nerve pain treatment didn't work or caused side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 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 achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score
Secondary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)
Time to ≥ 4-point improvement from baseline in Itch NRS score

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03569371
30%
Upper respiratory tract infection
10%
Rash
10%
Night sweats
10%
Nausea
10%
Fibromyalgia
10%
Headache
10%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: INCB054707 Dose CExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Group II: INCB054707 Dose BExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Group III: INCB054707 Dose AExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Group IV: Placebo followed by INCB054707 Dose B or CPlacebo Group1 Intervention
Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,019 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
204 Patients Enrolled for Prurigo Nodularis
Kathleen Butler, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,544 Total Patients Enrolled

Media Library

INCB054707 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05061693 — Phase 2
Prurigo Nodularis Research Study Groups: INCB054707 Dose A, INCB054707 Dose B, INCB054707 Dose C, Placebo followed by INCB054707 Dose B or C
Prurigo Nodularis Clinical Trial 2023: INCB054707 Highlights & Side Effects. Trial Name: NCT05061693 — Phase 2
INCB054707 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061693 — Phase 2

Frequently Asked Questions

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

Could you please elaborate on the risks associated with INCB054707?

"INCB054707 falls into Phase 2 of clinical trials. While there is data suggesting it is safe, none of the trials have yet shown that it is an effective medication."

Answered by AI

How many patients are being monitored in this clinical trial?

"One hundred and forty participants who satisfy the prerequisites are needed for this experiment. Those taking part can do so from various locations, such as Investigative Site US024 in Phoenix, Arizona or Investigative Site US018 in Dallas, Texas."

Answered by AI

In how many different countries is this trial taking place?

"28 clinical sites are enrolling patients for this trial, such as Investigative Site US024 in Phoenix, Investigative Site US018 in Dallas, and Investigative Site US005 in Austin. There are also enrolment locations."

Answered by AI

Are new participants being sought for this experiment?

"The trial you are inquiring about is, as of now, searching for patients to participate. This information was updated as recently as November 15th, 2021 on clinicaltrials.gov. The trial was originally posted almost a year ago on November 4th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Investigative Site US003
Investigative Site CA001
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
2021. "A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061693.
All > Prurigo Nodularis
~43 spots leftby Apr 2025
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