Atopic DermatitisADMIRENCT05451316
A Study to Assess Change in Disease Activity in Adolescents and Adults With Moderate to Severe Prurigo-type Atopic Dermatitis in Japan Who Are Treated With Oral Upadacitinib
An observational study of Atopic Dermatitis, run by AbbVie at 1 site in Japan.
Trial summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 8 Dec 2022to 2 Nov 2024
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescents and adults, age ≥ 12 years, with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed UPA according to the label and practice in Japan. The decision to prescribe UPA will be made prior to and independent of study participation
Who may be able to join
- Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline
- AD symptom onset > 1 year prior to baseline
- Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan
- Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline
- Presence of palpable prurigo nodules at baseline
Who cannot join
- Prior treatment with UPA
- Contraindications to UPA
- Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
- PN caused by medication, metal allergy, infection, insect bite
- Current participation in interventional research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan.
UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan.
Read more
Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic.
- Conditions
- Atopic Dermatitis
- Keywords
- Prurigo Nodularis, Prurigo-type AD, Skin, Dermatology, Upadacitinib, ADMIRE, RINVOQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours in patients with moderate to severe AD, based on the following question: "On a scale 0 to 10, with 0 being 'no itch' and 10 being 'worst imaginable itch', how would you rate your itch at its worst during the past 24 hours?"
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start8 Dec 2022
- Primary completion2 Nov 2024
- Study completion2 Nov 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 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
- NCT05451316
- Sponsor's protocol ID
- P23-433
- Acronym
- ADMIRE
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
- ClinicalTrials.gov ID
- NCT05451316
- Acronym / sponsor ID
- ADMIRE / P23-433
- Conditions
- Atopic Dermatitis
- Keywords
- Prurigo Nodularis, Prurigo-type AD, Skin, Dermatology, Upadacitinib, ADMIRE, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 11 Jul 2022 (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.
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan.
UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan.
Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | – | –Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents and adults, age ≥ 12 years, with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed UPA according to the label and practice in Japan. The decision to prescribe UPA will be made prior to and independent of study participation
Key inclusion criteria (5 listed)
- Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline
- AD symptom onset > 1 year prior to baseline
- Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan
- Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline
- Presence of palpable prurigo nodules at baseline
Key exclusion criteria (5 listed)
- Prior treatment with UPA
- Contraindications to UPA
- Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
- PN caused by medication, metal allergy, infection, insect bite
- Current participation in interventional research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.
Time frame: Up to Week 12
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours in patients with moderate to severe AD, based on the following question: "On a scale 0 to 10, with 0 being 'no itch' and 10 being 'worst imaginable itch', how would you rate your itch at its worst during the past 24 hours?"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by AbbVie at 1 site in Japan.
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 5 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4. (time frame: Up to Week 12). 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 27 Feb 2026.