Atopic DermatitisPhase 4NCT06366932
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
A Phase 4 study testing Second-line systemic treatment and Folllow-up of second-line systemic treatment already started in people with Atopic Dermatitis, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Second-line systemic treatment and Folllow-up of second-line systemic treatment already started
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 25 Sep 2023to Sep 2025
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cohort 1:
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
- Cohort 2:
Show all 10Show fewer
- Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving authorized second-line systemic therapy at the time of selection.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Who cannot join
- Any investigational drug within 60 days prior to study drug administration.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
- Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Paz
Madrid, 28046
Irene García, MD, +34-912071466, irene.ucicec@gmail.com
About this study
Official title: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.
Read the detailed description
Primary outcome is the percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.
- Conditions
- Atopic Dermatitis
- Being tested
- Second-line systemic treatment, Folllow-up of second-line systemic treatment already started
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-line systemic treatmentDrug
Also called Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib
Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in whom the use of cyclosporine is considered inappropriate due to contraindication or intolerance, are candidates for treatment with other alternatives (Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib).
Folllow-up of second-line systemic treatment already startedOther
If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: patients who are about to initiate treatment | Other | Patients will receive the dose used in routine clinical practice.
Once the patient is included in the clinical trial their therapeutic management will be conducted according to standard clinical practice, but some additional procedures will be performed:
1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life.
2. Blood samples will be obtained for biochemical, pharmacogenetic and immunological biomarker analysis Receives: Drug: Second-line systemic treatment |
| Cohort 2: patients who are already receiving second-line systemic treatment | Other | If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. Receives: Other: Folllow-up of second-line systemic treatment already started |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with primary non-response to second-line treatment.
Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index [EASI] score). The minimum EASI score is 0 and the maximum EASI score is 72.
Measured: Week 16
Secondary outcomes (14)
Percentage of patients achieving EASI-75
Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index [EASI] score). The minimum EASI score is 0 and the maximum EASI score is 72.
Measured: Week 6
Time to treatment failure after week 16
Time to treatment failure with cyclosporine defined as Eczema Area and Severity Index (EASI) ≤ 50 during follow-up after week 16.
Measured: Week 16
Mean percentage of change in Eczema Area and Severity Index (EASI) score
Mean percentage of change in EASI score from baseline to week 16.
Measured: Week 16
Percentage of change in SCORAD (SCORing Atopic Dermatitis)
Is the score of the severity of atopic dermatitis. It includes the evaluation of the affected areas. The intensity of the lesions and the subjective symptoms of the patient. Classifies AD as Mild >25, Moderate 25-50, and Severe >50
Measured: Week 16
Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)
Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value.
The SCORAD for that individual is A/5 + 7B/2 + C. The total area is 'A', which has a possible maximum of 100%. The intensity scores are added together to give 'B' (maximum 18). The subjective symptoms is 'C' (maximum 20).
Measured: Through study completion, an average of 1 year
Change of IGA (Investigator Global Assessment)
Investigator Global Assessment (IGA) is a simple objective measure providing an overall evaluation. It uses a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4).
Measured: Week 16
Time to IGA score of 0/1 (Investigator Global Assessment)
Time to IGA score of 0/1 (clear or almost clear).
Measured: Through study completion, an average of 1 year
Change of BSA (Body surface area)
Change of BSA (Body surface area) involment
Measured: Week 16
Change in NRS
Change in NRS (numerical rating scale). The NRS is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch").
Measured: Week 16
Change in RECAP
RECAP (Recap of atopic eczema) is used to assess the control of different degrees of eczema severity through 7 items.
Measured: Week 16
Percentage of patients having a variation of 4 points in their improvement in DLQI
Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years). A variation of 4 points is considered a clinically meaningful endpoint.
Measured: Through study completion, an average of 1 year
Change in POEM (Patient-Oriented Eczema Measure)
The Patient-Oriented Eczema Measure (POEM): is a validated tool in which the patient self-assesses how many days they experienced seven distinct items (itch, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, dryness of the skin) during a period of 1 week. The maximum score is 28 points.
Measured: Week 16
Rate of adverse events associated to second-line systemic treatment
Any untoward medical occurrence in a patient or clinical trial participant, which does not necessarily have a causal relationship with the research procedures or the investigational medicinal product.
Measured: Through study completion, an average of 1 year
Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage)
Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up. The minimum EASI (Eczema Area and Severity Index) score is 0 and the maximum EASI score is 72.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start25 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene García, MD, Principal investigator, Hospital La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366932
- Sponsor's protocol ID
- DermAtOmics-II
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)
- ClinicalTrials.gov ID
- NCT06366932
- Acronym / sponsor ID
- DermAtOmics-II
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 16 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.
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.
Detailed description
Primary outcome is the percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: patients who are about to initiate treatment | Other | Drug: Second-line systemic treatmentPatients will receive the dose used in routine clinical practice. Once the patient is included in the clinical trial their therapeutic management will be conducted according to standard clinical practice, but some additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life. 2. Blood samples will be obtained for biochemical, pharmacogenetic and immunological biomarker analysis |
| Cohort 2: patients who are already receiving second-line systemic treatment | Other | Other: Folllow-up of second-line systemic treatment already startedIf the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
- Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving authorized second-line systemic therapy at the time of selection.
Key exclusion criteria (4 listed)
- Any investigational drug within 60 days prior to study drug administration.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
- Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
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 |
|---|---|---|
| Second-line systemic treatmentAlso: Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, AbrocitinibPatients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in whom the use of cyclosporine is considered inappropriate due to contraindication or intolerance, are candidates for treatment with other alternatives (Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib). | Drug | Cohort 1: patients who are about to initiate treatment |
| Folllow-up of second-line systemic treatment already startedIf the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. | Other | Cohort 2: patients who are already receiving second-line systemic treatment |
Primary outcome
Percentage of patients with primary non-response to second-line treatment.
Time frame: Week 16
Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index [EASI] score). The minimum EASI score is 0 and the maximum EASI score is 72.
14 secondary outcomes
Percentage of patients achieving EASI-75
Time frame: Week 6
Time to treatment failure after week 16
Time frame: Week 16
Mean percentage of change in Eczema Area and Severity Index (EASI) score
Time frame: Week 16
Percentage of change in SCORAD (SCORing Atopic Dermatitis)
Time frame: Week 16
Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)
Time frame: Through study completion, an average of 1 year
Change of IGA (Investigator Global Assessment)
Time frame: Week 16
Time to IGA score of 0/1 (Investigator Global Assessment)
Time frame: Through study completion, an average of 1 year
Change of BSA (Body surface area)
Time frame: Week 16
Change in NRS
Time frame: Week 16
Change in RECAP
Time frame: Week 16
Percentage of patients having a variation of 4 points in their improvement in DLQI
Time frame: Through study completion, an average of 1 year
Change in POEM (Patient-Oriented Eczema Measure)
Time frame: Week 16
Rate of adverse events associated to second-line systemic treatment
Time frame: Through study completion, an average of 1 year
Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis
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.
Irene García, MD principal investigator
Hospital La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Second-line systemic treatment and Folllow-up of second-line systemic treatment already started in people with Atopic Dermatitis, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene García, MD (+34-912071466, irene.ucicec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with primary non-response to second-line treatment. (time frame: Week 16). 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 16 Apr 2024.