Atopic DermatitisPhase 3Sleep UpNCT06390722
A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis and Sleep Disturbance, run by AbbVie.
Trial summary
Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families. Read more about this study
- Who is it for?
- Ages 25 to 63 years
- Conditions the study is for
- Atopic Dermatitis, Sleep Disturbance
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2024to 8 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AD, according to Hanifin and Rajka criteria, with onset of symptoms at least 3 years prior to Baseline.
- Eczema Area and Severity Index (EASI) score >= 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score >= 3, and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
- Baseline weekly average of daily Worst Pruritus Numeric Rating Scale (NRS) >= 7.
- Moderate to severe sleep disturbance as confirmed by Baseline Patient Global Impression (PGI) Sleep AD (7-day) score of 3 or 4.
- Documented history of inadequate response to at least 1 prior systemic treatment for AD OR for whom systemic treatments, other than upadacitinib, are medically inadvisable (e.g., because of important side effects or safety risks).
Who cannot join
- Prior exposure to dupilumab, tralokinumab, lebrikizumab, or nemolizumab.
- Conditions or circumstances that could interfere with sleep assessments, including but not limited to:
- History of sleep apnea, hypersomnia, or insomnia related to chronic pain;
- Participant uses a continuous positive airway pressure (CPAP) machine;
- History of chronic obstructive pulmonary disease or uncontrolled asthma;
- Evidence of restless leg syndrome;
Show all 9Show fewer
- Participant is an evening or night shift worker;
- Participant has sleep disturbance due to menopause, nocturia, or situational circumstances (e.g., caring for infant).
- Participants who had prior exposure to any oral JAK inhibitor
About this study
Official title: A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)
Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families.
Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score in Phase 3 registrational trials, but objective data on upadacitinib's effect on elements of sleep disturbance such as Wake After Sleep Onset, or Sleep Efficiency, have not been collected.
Read more
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 Periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo. In Period 2, participants will be switched to receive open-label upadacitnib. Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide.
This study consists of a 35-day Screening Period; a 2-week randomized, double-blinded period (Period 1); a 22-week open-label extension period (Period 2); and a 30-day follow-up visit/call. Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Atopic Dermatitis, Sleep Disturbance
- Being tested
- Upadacitinib, Placebo for Upadacitinib
- Keywords
- Upadacitinib, RINVOQ, ABT-494, Atopic Dermatitis, Sleep Disturbance
- Medical subject headings
- Dermatitis, Atopic, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called RINVOQ
Oral Tablet
Placebo for UpadacitinibDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Experimental | Participants randomized to receive upadacitinib Dose A once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks. Receives: Drug: Upadacitinib |
| Placebo | Placebo comparator | Participants randomized to receive Placebo once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks. Receives: Drug: Placebo for Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline
The Worst Pruritus Numeric Rating Scale is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
Measured: Baseline to Week 2
Secondary outcomes (4)
Change from Baseline in Total Scratch Time
Scratch time will be measured in duration of seconds based on a wearable scratch sensor per sleep opportunity hour at Week 2 .
Note: Sleep opportunity is defined as total time spent trying to sleep [i.e., sleep sensor on to sensor off time].
Measured: Baseline to Week 2
Change from Baseline in Sleep Efficiency
A wearable sleep sensor collects actigraphy, temperature, and heart rate data to quantify sleep parameters
Measured: Baseline to Week 2
Change from Baseline in Wake After Sleep Onset (WASO) based on a sleep sensor.
A wearable sleep sensor collects actigraphy, temperature, and heart rate data to quantify sleep parameters
Measured: Baseline to Week 2
Change from Baseline in Nocturnal Scratching Bouts (≥ 5 seconds)
Scratch time will be measured in duration of seconds based on a wearable scratch sensor per sleep opportunity hour at Week 2 .
Note: Sleep opportunity is defined as total time spent trying to sleep [i.e., sleep sensor on to sensor off time].
Measured: Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start23 May 2024 (estimated)
- Primary completion5 Jan 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Why it stopped: strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390722
- Sponsor's protocol ID
- M24-602
- Acronym
- Sleep Up
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)
- ClinicalTrials.gov ID
- NCT06390722
- Acronym / sponsor ID
- Sleep Up / M24-602
- Conditions
- Atopic Dermatitis, Sleep Disturbance
- Keywords
- Upadacitinib, RINVOQ, ABT-494, Atopic Dermatitis, Sleep Disturbance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 23 May 2024 (estimated)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 8 Jul 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families.
Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score in Phase 3 registrational trials, but objective data on upadacitinib's effect on elements of sleep disturbance such as Wake After Sleep Onset, or Sleep Efficiency, have not been collected.
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 Periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo. In Period 2, participants will be switched to receive open-label upadacitnib. Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide.
This study consists of a 35-day Screening Period; a 2-week randomized, double-blinded period (Period 1); a 22-week open-label extension period (Period 2); and a 30-day follow-up visit/call. Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | Experimental | Drug: UpadacitinibParticipants randomized to receive upadacitinib Dose A once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks. |
| Placebo | Placebo comparator | Drug: Placebo for UpadacitinibParticipants randomized to receive Placebo once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks. |
Who may qualify
- Ages
- 25 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- AD, according to Hanifin and Rajka criteria, with onset of symptoms at least 3 years prior to Baseline.
- Eczema Area and Severity Index (EASI) score >= 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score >= 3, and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
- Baseline weekly average of daily Worst Pruritus Numeric Rating Scale (NRS) >= 7.
- Moderate to severe sleep disturbance as confirmed by Baseline Patient Global Impression (PGI) Sleep AD (7-day) score of 3 or 4.
- Documented history of inadequate response to at least 1 prior systemic treatment for AD OR for whom systemic treatments, other than upadacitinib, are medically inadvisable (e.g., because of important side effects or safety risks).
Key exclusion criteria (9 listed)
- Prior exposure to dupilumab, tralokinumab, lebrikizumab, or nemolizumab.
- Conditions or circumstances that could interfere with sleep assessments, including but not limited to:
- Participants who had prior exposure to any oral JAK inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibAlso: RINVOQOral Tablet | Drug | Upadacitinib |
| Placebo for UpadacitinibOral Tablet | Drug | Placebo |
Primary outcome
Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline
Time frame: Baseline to Week 2
The Worst Pruritus Numeric Rating Scale is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.
4 secondary outcomes
Change from Baseline in Total Scratch Time
Time frame: Baseline to Week 2
Change from Baseline in Sleep Efficiency
Time frame: Baseline to Week 2
Change from Baseline in Wake After Sleep Onset (WASO) based on a sleep sensor.
Time frame: Baseline to Week 2
Change from Baseline in Nocturnal Scratching Bouts (≥ 5 seconds)
Time frame: Baseline to Week 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis and Sleep Disturbance, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline (time frame: Baseline to Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.