Atopic Dermatitis (AD)Phase 3NCT04666675
A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil
A Phase 3 study testing Upadacitinib in people with Atopic Dermatitis (AD), run by AbbVie.
Trial summary
Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- 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
- 24 Dec 2020to 23 Mar 2021
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age.
- Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits.
- Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits.
- >= 10% body surface area of AD involvement at the Screening and Baseline Visits.
- Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 at Screening and Baseline Visits.
- Documented history (within 1 year prior to the Screening Visit) of inadequate response (IR) to systemic methotrexate (MTX) and/or cyclosporin A (CsA) or not a candidate for systemic treatment with MTX or CsA as a result of intolerance or medical contraindication.
Who cannot join
- Prior exposure to any systemic Janus kinase (JAK) inhibitor.
- Prior exposure to dupilumab.
- Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
- Corticosteroids, MTX, CsA, azathioprine. phosphodiesterase type 4 (PDE4)-inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks.
- Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer.
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
- Oral or parenteral traditional medicine within 4 weeks.
- Moisturizers that contain Topical corticosteroids (TCS), Topical calcineurin inhibitor (TCI)s, or topical Phosphodiesterase type 4 (PDE-4) inhibitors within 7 days.
About this study
Official title: A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil
Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms.
Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil.
Read more
Participants will receive the following for up to 52 weeks:
Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52.
Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52.
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Upadacitinib, Placebo for Upadacitinib
- Keywords
- Atopic Dermatitis, Upadacitinib, ABT-494, 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.
UpadacitinibDrug
Also called Rinvoq, ABT-494
Oral; Tablet
Placebo for UpadacitinibDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib Dose A | Experimental | Participants will receive Upadacitinib Dose A once daily (QD). Receives: Drug: Upadacitinib |
| Upadacitinib Dose B | Experimental | Participants will receive Upadacitinib Dose B QD. Receives: Drug: Upadacitinib |
| Placebo for Upadacitinib Followed by Upadacitinib Dose A | Experimental | Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD. Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib |
| Placebo for Upadacitinib Followed by Upadacitinib Dose B | Experimental | Participants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD. Receives: Drug: Upadacitinib; 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 at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Measured: Baseline to Week 16
Number of Participants With Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Week 52
Secondary outcomes (1)
Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start24 Dec 2020 (estimated)
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, 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
- NCT04666675
- Sponsor's protocol ID
- M20-412
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 and 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil
- ClinicalTrials.gov ID
- NCT04666675
- Acronym / sponsor ID
- M20-412
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis, Upadacitinib, ABT-494, Rinvoq
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (estimated)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 14 Dec 2020 (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 chronic inflammatory skin disease that is characterized by intense itching, oozing and crusting, redness, skin erosion and dry skin. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat participants with moderate to severe AD in Brazil. The study will assess change in disease signs and symptoms.
Upadacitinib is an investigational drug being developed for the treatment of Atopic Dermatitis (AD). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Participants with a diagnosis of AD will be enrolled. Around 150 participants will be enrolled in the study in approximately 20 sites in Brazil.
Participants will receive the following for up to 52 weeks:
Participants will receive oral upadacitinib tablets once daily for up to week 52. Participants may also receive oral placebo tablets once daily up to week 16 followed by oral upadacitinib tablets once daily up to week 52.
Arm 1: Upadacitinib Dose A up to week 52. Arm 2: Upadacitinib Dose B up to week 52. Arm 3: Placebo up to week 16 followed by upadacitinib Dose A up to week 52. Arm 4: Placebo up to week 16 followed by upadacitinib Dose B up to week 52.
There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib Dose A | Experimental | Drug: UpadacitinibParticipants will receive Upadacitinib Dose A once daily (QD). |
| Upadacitinib Dose B | Experimental | Drug: UpadacitinibParticipants will receive Upadacitinib Dose B QD. |
| Placebo for Upadacitinib Followed by Upadacitinib Dose A | Experimental | Drug: Upadacitinib, Drug: Placebo for UpadacitinibParticipants will receive placebo for Upadacitinib followed by Upadacitinib Dose A QD. |
| Placebo for Upadacitinib Followed by Upadacitinib Dose B | Experimental | Drug: Upadacitinib, Drug: Placebo for UpadacitinibParticipants will receive placebo for Upadacitinib followed by Upadacitinib Dose B QD. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Body weight >= 40 kg at the Baseline Visit for participants between >= 12 and < 18 years of age.
- Chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Baseline Visits.
- Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3 at the Screening and Baseline Visits.
- >= 10% body surface area of AD involvement at the Screening and Baseline Visits.
Key exclusion criteria (8 listed)
- Prior exposure to any systemic Janus kinase (JAK) inhibitor.
- Prior exposure to dupilumab.
- Must not have used the following AD treatments within the specified timeframe prior to Baseline Visit:
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: Rinvoq, ABT-494Oral; Tablet | Drug | Placebo for Upadacitinib Followed by Upadacitinib Dose A, Placebo for Upadacitinib Followed by Upadacitinib Dose B, Upadacitinib Dose A, Upadacitinib Dose B |
| Placebo for UpadacitinibOral; Tablet | Drug | Placebo for Upadacitinib Followed by Upadacitinib Dose A, Placebo for Upadacitinib Followed by Upadacitinib Dose B |
Primary outcome
Percentage of Participants Achieving at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline
Time frame: Baseline to Week 16
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Number of Participants With Adverse Events (AE)
Time frame: Up to Week 52
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
1 secondary outcome
Percentage of Participants Achieving at least a 90% Reduction in Eczema Area and Severity Index (EASI 90) from Baseline
Time frame: Baseline to Week 16
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 8 Apr 2021.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- 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 and 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.
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
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 (AD), 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 7 inclusion and 8 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 8 Apr 2021. 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. 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 at least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. 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 8 Apr 2021.