All > Prurigo Nodularis

INCB054707 for Prurigo Nodularis

Investigative Site PL006, Warsaw, Poland
Prurigo NodularisINCB054707 - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Prurigo Nodularis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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CardiolRx
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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to Week 48

Up to Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time to ≥ 4-point improvement from baseline in Itch NRS score
Week 16
Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)
Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
CardiolRx
1
5 Percent TolaSure Topical Gel
1
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Side Effects for

INCB054707
30%Upper respiratory tract infection
10%Nausea
10%Fibromyalgia
10%Headache
10%Anxiety
10%Night sweats
10%Rash
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03569371) in the INCB054707 ARM group. Side effects include: Upper respiratory tract infection with 30%, Nausea with 10%, Fibromyalgia with 10%, Headache with 10%, Anxiety with 10%.

Trial Design

4 Treatment Groups

INCB054707 Dose A
1 of 4
INCB054707 Dose B
1 of 4
INCB054707 Dose C
1 of 4
Placebo followed by INCB054707 Dose B or C
1 of 4

Experimental Treatment

Non-Treatment Group

145 Total Participants · 4 Treatment Groups

Primary Treatment: INCB054707 · Has Placebo Group · Phase 2

INCB054707 Dose A
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
INCB054707 Dose B
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
INCB054707 Dose C
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Placebo followed by INCB054707 Dose B or C
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 48

Who is running the clinical trial?

Incyte CorporationLead Sponsor
330 Previous Clinical Trials
47,785 Total Patients Enrolled
1 Trials studying Prurigo Nodularis
180 Patients Enrolled for Prurigo Nodularis
Kathleen Butler, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,631 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There are additional requirements for participation in the study.
You have been diagnosed with PN (peripheral neuropathy) for at least 3 months before screening.
You did not respond well to or could not tolerate previous treatment for peripheral neuropathy.
You are not trying to have a baby or make someone pregnant during the study.
You have at least 20 itchy bumps on two or more different areas of your body during the screening and on the first day of the study.

Who else is applying?

What state do they live in?
Maryland100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Investigative Site US00350.0%
Investigative Site CA00150.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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