Lupus Erythematosus, SystemicDAHLIANCT07330245
Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 22 sites in Italy.
Trial summary
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Anifrolumab
- How many people
- 218 participants
- Where
- 22 sitesItaly
- Study dates
- 31 Dec 2025to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
Who may be able to join
- Provided informed consent to participate in the study;
- Aged 18 years or older;
- Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
- Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;
Who cannot join
- Patients who are at LLDAS5 at the time of study entry;
- Previous exposure to anifrolumab;
- Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy [mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
- Currently participating in any interventional clinical trial with an investigational product;
- Inability to understand and sign the informed consent and to fill in patient questionnaires
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
22 sites in 1 country
Italy22 sites, 21 recruiting
- Recruiting
AOU Ospedali Riuniti di Ancona - Presidio Torrette
Ancona, 60126
- Withdrawn
Azienda Ospedaliero-Universitaria Policlinico di Bari
Bari, 70124
- Recruiting
ASST Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
Cona, Ferrara, 44124
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan
- Not yet recruiting
Policlinico di Modena - AOU di Modena
Modena, 41124
- Recruiting
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
Monserrato, CA, 09032
- Not yet recruiting
Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Naples
- Not yet recruiting
Azienda Ospedaliera di Padova
Padova, 35128
- Recruiting
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, 90127
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
- Not yet recruiting
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
Pisa, 56126
- Not yet recruiting
Policlinico Tor Vergata
Roma, 00133
- Recruiting
Policlinico Umberto I - Sapienza Università di Roma
Roma, 00161
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
- Recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia
- Not yet recruiting
Azienda Ospedaliera Ordine Mauriziano Umberto I
Torino, 10128
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, 34128
- Recruiting
ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
Udine, 33100
- Recruiting
AOUI Verona - Ospedale Borgo Roma
Verona, 37134
About this study
Official title: DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
Read the detailed description
DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Anifrolumab
- Keywords
- Lupus Erythematosus, Systemic., Anifrolumab.
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabBiological
Also called Saphnelo
anifrolumab - fully human monoclonal antibody target type I INF
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients achieving LLDAS5
proportion of patients with LLDAS5 at 52 weeks, defined as:
LLDAS5 is defined as follows:
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity;
- No new lupus disease activity compared with previous assessment as defined per protocol;
- Physician's Global Assessment (PGA) ≤1;
- Current prednisone (-equivalent) dose ≤ 5mg/day;
- Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
Measured: 52 weeks
Secondary outcomes (11)
Number and percentage of patients reaching LLDAS5 at each time point
Proportion of patients with LLDAS5, according the following definition:
LLDAS5 is defined as follows:
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity;
- No new lupus disease activity compared with previous assessment as defined per protocol;
- Physician's Global Assessment (PGA) ≤1;
- Current prednisone (-equivalent) dose ≤ 5mg/day;
- Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
Measured: week 24, 76 and 104
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0
Measured: week 4, 12, 24, 52, 76, 104 vs baseline
Median (range) cumulative dose of GCS
Median cumulative dose of GCS calculated at each 6 month period following T0
Measured: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
Mean(SD) change in tender and swollen joint count
Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity)
Measured: week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Power Doppler (PD) Signal Total score
Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high)
Measured: week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Synovial Hypertrophy (SH) Total score
Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high).
Measured: week 4, 12, 24, 52, 76 and 104 vs week 0
Annualize flaire rate
Annualized flare rate in the first and second years
Measured: week 52 and week 104
Number and percentage of patients meeting the DORIS clinical remission
Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:
- Clinical SLEDAI-2K = 0;
- PGA < 0.5;
- Prednisolone ≤ 5 mg/day
Measured: week 12, 24, 52, 76 and 104
Number and percentage of patients with sustained DORIS remission
Number and percentage of patients with sustained DORIS remission, defined as remaining in remission at or greater than 12 weeks after having met the DORIS definition
Measured: week 104
Mean (SD) HDRS (Hamilton Depression Rating Scale) total score
Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe)
Measured: week 12, 24, 52 and 104 vs week 0
Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score
Change in PROMIS Depression Short Form 8b total score at different timepoints compared to week 0 (baseline). PROMIS raw scores ranges from 8 (no depression) to 40 (severe)
Measured: week 12, 24, 52 and 104 vs week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start31 Dec 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330245
- Sponsor's protocol ID
- D3461R00093
- Acronym
- DAHLIA
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy
- ClinicalTrials.gov ID
- NCT07330245
- Acronym / sponsor ID
- DAHLIA / D3461R00093
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Lupus Erythematosus, Systemic., Anifrolumab.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Jan 2026 (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 an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
Detailed description
DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
Key inclusion criteria (4 listed)
- Provided informed consent to participate in the study;
- Aged 18 years or older;
- Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
- Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;
Key exclusion criteria (5 listed)
- Patients who are at LLDAS5 at the time of study entry;
- Previous exposure to anifrolumab;
- Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy [mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
- Currently participating in any interventional clinical trial with an investigational product;
- Inability to understand and sign the informed consent and to fill in patient questionnaires
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 |
|---|---|---|
| AnifrolumabAlso: Saphneloanifrolumab - fully human monoclonal antibody target type I INF | Biological | – |
Primary outcome
Number and percentage of patients achieving LLDAS5
Time frame: 52 weeks
proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows: * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; * No new lupus disease activity compared with previous assessment as defined per protocol; * Physician's Global Assessment (PGA) ≤1; * Current prednisone (-equivalent) dose ≤ 5mg/day; * Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
11 secondary outcomes
Number and percentage of patients reaching LLDAS5 at each time point
Time frame: week 24, 76 and 104
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
Time frame: week 4, 12, 24, 52, 76, 104 vs baseline
Median (range) cumulative dose of GCS
Time frame: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
Mean(SD) change in tender and swollen joint count
Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Power Doppler (PD) Signal Total score
Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Synovial Hypertrophy (SH) Total score
Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0
Annualize flaire rate
Time frame: week 52 and week 104
Number and percentage of patients meeting the DORIS clinical remission
Time frame: week 12, 24, 52, 76 and 104
Number and percentage of patients with sustained DORIS remission
Time frame: week 104
Mean (SD) HDRS (Hamilton Depression Rating Scale) total score
Time frame: week 12, 24, 52 and 104 vs week 0
Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score
Time frame: week 12, 24, 52 and 104 vs week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
AstraZeneca Clinical Study Information Center contact
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 22 sites in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients achieving LLDAS5 (time frame: 52 weeks). 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 21 Sep 2026.