The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
Megadott ok: The study was terminated due to lack of enrollment.
Key facts
- Where
- Arlington, Boca Raton, Boston, Brooklyn, Burke, Charleston, Clarksville, Coral Gables, Dayton, East Syracuse, Fountain Valley, Gainesville, Hollywood, Indianapolis, Long Beach, Louisville, Methuen, Miami, Natick, New York, Pittsburgh, Portland, Richmond, Rochester, South Jordan, Spokane, St Louis, Tampa és Washington D.C., Egyesült ÁllamokSee the 30 sites
- Phase
- 4. fázis
Where in Egyesült Államok
- Arlington Research CenterArlington, Egyesült ÁllamokNo longer taking part
- Skin Care Research, LLCBoca Raton, Egyesült ÁllamokNo longer taking part
- Beth Israel Deaconess Medical Center (BIDMC)Boston, Egyesült ÁllamokNo longer taking part
- SUNY Downstate Health Sciences UniversityBrooklyn, Egyesült ÁllamokNo longer taking part
- Pi Coor Clinical Research LlcBurke, Egyesült ÁllamokNo longer taking part
- Clinical Research Center of the CarolinasCharleston, Egyesült ÁllamokNo longer taking part
- Dermatology Specialists Research IndianaClarksville, Egyesült ÁllamokNo longer taking part
- Driven Research LLCCoral Gables, Egyesült ÁllamokNo longer taking part
- Ohio Pediatric Research AssociationDayton, Egyesült ÁllamokNo longer taking part
- Empire DermatologyEast Syracuse, Egyesült ÁllamokNo longer taking part
- First OC DermatologyFountain Valley, Egyesült ÁllamokNo longer taking part
- University of Florida Health Dermatology-SpringhillGainesville, Egyesült ÁllamokNo longer taking part
- Skin Care Research, Llc Scr HollywoodHollywood, Egyesült ÁllamokNo longer taking part
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, Egyesült ÁllamokNo longer taking part
- Ark Clinical ResearchLong Beach, Egyesült ÁllamokNo longer taking part
- Skin Sciences, PLLCLouisville, Egyesült ÁllamokNo longer taking part
- Northeast Dermatology AssociatesMethuen, Egyesült ÁllamokNo longer taking part
- Ciocca Dermatology PaMiami, Egyesült ÁllamokNo longer taking part
- Essential DermatologyNatick, Egyesült ÁllamokNo longer taking part
- Sadick DermatologyNew York, Egyesült ÁllamokNo longer taking part
- University of PittsburghPittsburgh, Egyesült ÁllamokNo longer taking part
- Knight Cancer Institute at Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- Oregon Dermatology and Research CenterPortland, Egyesült ÁllamokNo longer taking part
- Clinical Research Partners, LLCRichmond, Egyesült ÁllamokNo longer taking part
- Skin Search of RochesterRochester, Egyesült ÁllamokNo longer taking part
- Jordan Valley Dermatology CenterSouth Jordan, Egyesült ÁllamokNo longer taking part
- Dermatology Specialists of SpokaneSpokane, Egyesült ÁllamokNo longer taking part
- Washington University School of Medicine DermatologySt Louis, Egyesült ÁllamokNo longer taking part
- TrueBlue Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Gw Training CenterWashington D.C., Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT05696392
- Record updated
- 2025. december 19.
- Original description
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.Read full original descriptionShow less
An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Inclusion: Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria; Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant); Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits; Has an IGA score ≥ 2 at the screening and baseline visits; Has an Itch NRS score ≥ 4 at the screening and baseline visits; Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study; Agrees to maintain a regular sleep schedule during the study period; Willing and able to follow required study procedures for measuring sleep for the duration of the study.
Exclusion: Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study; Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant); Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period; Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period; Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study; Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period; Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems; Has a known or suspected allergy to ruxolitinib or any component of the study drug; Currently has a schedule that includes nighttime work shifts.