Ruxolitinib Cream for Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Jordan Valley Medical Center, West Jordan, UT
Dermatitis+3 More
Ruxolitinib Cream - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Eligible Conditions

  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Dermatitis

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)

Week 56
Number of Treatment-emergent adverse events (TEAEs)
Week 52
Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values
Number of participants with clinically notable vital sign changes from baseline
Number of participants with clinically significant changes from Baseline in height
Number of participants with clinically significant changes from Baseline in weight
Week 12
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Dermatitis

Side Effects for

Vehicle Cream BID
4%Headache
3%Upper respiratory tract infection
2%Nasopharyngitis
1%Nasal sinus cancer
1%Dermatitis atopic
0%Jaundice cholestatic
0%Femur fracture
0%Dizziness
0%Hypovolaemia
0%Pyrexia
0%Cholangitis
0%Humerus fracture
0%Rib fracture
0%Substance-induced psychotic disorder
0%Central nervous system lesion
0%Pneumonia
0%Cholelithiasis
0%Pelvic fracture
0%Acute abdomen
0%Serositis
0%Anaemia postoperative
0%Colitis
0%Bronchitis
0%Ulna fracture
0%Radius fracture
0%Cholecystitis infective
0%Type 2 diabetes mellitus
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03745638) in the Vehicle Cream BID ARM group. Side effects include: Headache with 4%, Upper respiratory tract infection with 3%, Nasopharyngitis with 2%, Nasal sinus cancer with 1%, Dermatitis atopic with 1%.

Trial Design

1 Treatment Group

Ruxolitinib
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Ruxolitinib Cream · No Placebo Group · Phase 3

Ruxolitinib
Drug
Experimental Group · 1 Intervention: Ruxolitinib Cream · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Cream
2018
Completed Phase 3
~640

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)
Closest Location: Jordan Valley Medical Center · West Jordan, UT
Photo of utah 1Photo of utah 2Photo of utah 3
2020First Recorded Clinical Trial
3 TrialsResearching Dermatitis
1 CompletedClinical Trials

Who is running the clinical trial?

Incyte CorporationLead Sponsor
301 Previous Clinical Trials
44,680 Total Patients Enrolled
18 Trials studying Dermatitis
7,075 Patients Enrolled for Dermatitis
Brett Angel, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Dermatitis
250 Patients Enrolled for Dermatitis

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had an acute or subacute onset of an autoimmune disease for at least 2 years.
You have a total IGA score of 2 to 3 at the screening and baseline visits.
Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.
You have atopic dermatitis that is not adequately controlled with other topical prescription therapies or when those therapies are not advisable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.