Systemic Lupus ErythematosusPRIMULA DUSNCT07431775
Saphnelo Use in Females of Child-bearing Potential
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- How many people
- 26,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Mar 2032
- 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population for the primary objectives will be all female patients of reproductive potential (defined as females aged 15 to 50 years old) observed during the patient identification period. The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to a subset of the broader secondary objective population, and includes female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US.
Who may be able to join
- Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
- Female sex at index date
- Age ≥15 and ≤50 years at index date
- Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives).
- Female sex at index date.
- Age ≥15 and ≤50 years at index date.
- ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
- (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date.
Who cannot join
- (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
- Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
- Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.
Read the detailed description
Research Questions:
- What is the incidence and prevalence of anifrolumab use among females of reproductive potential in selected countries where anifrolumab is marketed?
- What are the baseline characteristics and drug utilization patterns in females of reproductive potential who initiate treatment with anifrolumab in selected countries where anifrolumab is marketed?
Primary Objectives:
1a. To describe trends in the annual incidence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
1b. To describe trends in the annual prevalence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
Secondary Objectives:
- To describe the demographic and clinical characteristics of females of reproductive potential who initiate anifrolumab use, at the point of treatment initiation.
- To describe SLE treatment regimens at anifrolumab initiation among females of reproductive potential with an SLE diagnosis.
- To describe anifrolumab utilization patterns among females of reproductive potential who initiate anifrolumab use.
- To enumerate and describe pregnancies with anifrolumab exposure among females of reproductive potential who initiate anifrolumab use.
This is a non-interventional, retrospective, descriptive cohort study using secondary healthcare data from selected countries where anifrolumab is marketed (specifically, Denmark, France, Germany, and the US) to assess trends in, and patterns of, anifrolumab use among females of reproductive potential.
The study population for the primary objectives will be female patients of reproductive potential (defined as females aged 15 to 50 years old) who are observable during the patient identification period (country-specific; market launch date through the end of available data). The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US.
Final study report delivery is planned for April 2032.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anifrolumab
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), post Marketing Requirements (PMR) study, pregnancy, Systemic Lupus Erythematosus
- 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.
AnifrolumabDrug
Also called Saphnelo
Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| Study population for primary objectives | Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year:
Inclusion criteria
1. Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
2. Female sex at index date
3. Age ≥15 and ≤50 years at index date
Exclusion criteria
1. (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
Note: Cohort selection criteria for the primary objectives will be assessed repeatedly within calendar year intervals during the patient identification period to enable evaluation of annual anifrolumab use incidence and prevalence outcomes. Receives: Drug: Anifrolumab | |
| Study population for secondary objectives | Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
Inclusion criteria
1. Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives)
2. Female sex at index date
3. Age ≥15 and ≤50 years at index date
4. ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
5. (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date
Exclusion criteria
1. Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date Receives: Drug: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anifrolumab use
Within each country, the incidence of anifrolumab will be assessed within each calendar year interval of the overall patient identification period. The follow-up period within each calendar year interval starts on the calendar year-specific index date and ends on the earliest of the following dates within that same year: (1) last date of observability (enrollment/activity), (2) death date, (3) 51st birthday, (4) end of the study period, (5) December 31st (end of calendar year), or (6) date of anifrolumab initiation (for objective 1a only). Incidence will be reported as the number of female patients of reproductive potential with incident anifrolumab use per (1) 1,000,000 females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI and (2) per 1,000,000 person-years of follow-up among females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI.
Measured: 1 year
Prevalence of anifrolumab use
Within each country, the prevalence of anifrolumab use will be assessed within each calendar year interval of the follow-up period by calculating the number and percentage with prevalent anifrolumab use among all female patients of reproductive potential in a given calendar year (with 95% CI), as well as number of female patients of reproductive potential with prevalent anifrolumab use per 1,000,000 female patients of reproductive potential in a given calendar year (with 95% CI).
Measured: 1 year
Secondary outcomes (4)
Baseline patient characteristics
Patient demographics and clinical characteristics for the secondary objective cohort will be assessed using descriptive statistics over the appropriate baseline period. Categorical variables will be reported as counts with percentages, and continuous variables will be reported as mean (SD) and median (IQR). The frequency (and proportion) of missing responses will be reported for baseline patient characteristics.
Measured: At anifrolumab treatment initiation (index date)
Baseline SLE treatment characteristics
Baseline SLE treatment utilization characteristics will be assessed over the appropriate baseline period among the patients in the secondary objective cohort with a baseline SLE diagnosis. The number and percentage of patients who have a record for each unique SLE treatment during the baseline assessment period will be reported.
Measured: At anifrolumab treatment initiation (index date)
Anifrolumab treatment utilization patterns
Anifrolumab treatment use outcomes will be assessed in the secondary objective cohort from one day after the index date until the earliest of: last date of observability, death, 51st birthday, end of study period, or anifrolumab discontinuation (end of first episode of use). Duration of anifrolumab use (in days) will be estimated using the Kaplan-Meier method, summarized as (1) median time on treatment (with 95% CI) and (2) proportion of patients still on treatment at 84 days (with 95% CI). Additional outcome measures include total count of doses per patient (mean, SD, median, IQR, range), and proportion with anifrolumab discontinuation (defined as a gap of 90+ days between infusions, with discontinuation date as 28 days after last dose before discontinuation) during follow-up.
Measured: From anifrolumab treatment initiation (index date) up to 84 days post-initiation
Anifrolumab-exposed pregnancies
Pregnancies that occur during anifrolumab exposure will be identified and assessed in the secondary objective cohort from one day after the index date until the earliest of: last date of observability, death, 51st birthday, end of study period, or last date of anifrolumab exposure (set as 93 days after last dose in first episode of use). Reported outcome measures will include: (1) total count of anifrolumab-exposed pregnancy episodes (cohort-level), (2) counts with percentages of patients who initiated anifrolumab use with 0, 1, or ≥2 unique anifrolumab-exposed pregnancy episodes, (3) number (and percentage) of patients who were pregnant at time of anifrolumab initiation, (4) trimester of pregnancy at anifrolumab initiation (counts/percentages for 1st, 2nd, or 3rd trimester), and (5) duration of anifrolumab exposure (mean, SD, median, IQR, range) among anifrolumab-exposed pregnancy episodes.
Measured: From anifrolumab treatment initiation (index date) up to 93 days after date of last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Retrospective
- Enrolment
- 26,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Responsible party
- Sponsor
- Investigators
- Zachary Bouck, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431775
- Sponsor's protocol ID
- D3461R00086
- Acronym
- PRIMULA DUS
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential
- ClinicalTrials.gov ID
- NCT07431775
- Acronym / sponsor ID
- PRIMULA DUS / D3461R00086
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), post Marketing Requirements (PMR) study, pregnancy, Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 26,000,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 25 Feb 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.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.
Detailed description
Research Questions:
- What is the incidence and prevalence of anifrolumab use among females of reproductive potential in selected countries where anifrolumab is marketed?
- What are the baseline characteristics and drug utilization patterns in females of reproductive potential who initiate treatment with anifrolumab in selected countries where anifrolumab is marketed?
Primary Objectives:
1a. To describe trends in the annual incidence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
1b. To describe trends in the annual prevalence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status.
Secondary Objectives:
- To describe the demographic and clinical characteristics of females of reproductive potential who initiate anifrolumab use, at the point of treatment initiation.
- To describe SLE treatment regimens at anifrolumab initiation among females of reproductive potential with an SLE diagnosis.
- To describe anifrolumab utilization patterns among females of reproductive potential who initiate anifrolumab use.
- To enumerate and describe pregnancies with anifrolumab exposure among females of reproductive potential who initiate anifrolumab use.
This is a non-interventional, retrospective, descriptive cohort study using secondary healthcare data from selected countries where anifrolumab is marketed (specifically, Denmark, France, Germany, and the US) to assess trends in, and patterns of, anifrolumab use among females of reproductive potential.
The study population for the primary objectives will be female patients of reproductive potential (defined as females aged 15 to 50 years old) who are observable during the patient identification period (country-specific; market launch date through the end of available data). The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US.
Final study report delivery is planned for April 2032.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study population for primary objectives | – | Drug: AnifrolumabPatients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year: Inclusion criteria 1. Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives) 2. Female sex at index date 3. Age ≥15 and ≤50 years at index date Exclusion criteria 1. (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date Note: Cohort selection criteria for the primary objectives will be assessed repeatedly within calendar year intervals during the patient identification period to enable evaluation of annual anifrolumab use incidence and prevalence outcomes. |
| Study population for secondary objectives | – | Drug: AnifrolumabPatients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria: Inclusion criteria 1. Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives) 2. Female sex at index date 3. Age ≥15 and ≤50 years at index date 4. ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date. 5. (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date Exclusion criteria 1. Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population for the primary objectives will be all female patients of reproductive potential (defined as females aged 15 to 50 years old) observed during the patient identification period. The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to a subset of the broader secondary objective population, and includes female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US.
Key inclusion criteria (8 listed)
- Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
- Female sex at index date
- Age ≥15 and ≤50 years at index date
- Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives).
- Female sex at index date.
Key exclusion criteria (3 listed)
- (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
- Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
- Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.
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 is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. | Drug | Study population for primary objectives, Study population for secondary objectives |
Primary outcome
Incidence of anifrolumab use
Time frame: 1 year
Within each country, the incidence of anifrolumab will be assessed within each calendar year interval of the overall patient identification period. The follow-up period within each calendar year interval starts on the calendar year-specific index date and ends on the earliest of the following dates within that same year: (1) last date of observability (enrollment/activity), (2) death date, (3) 51st birthday, (4) end of the study period, (5) December 31st (end of calendar year), or (6) date of anifrolumab initiation (for objective 1a only). Incidence will be reported as the number of female patients of reproductive potential with incident anifrolumab use per (1) 1,000,000 females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI and (2) per 1,000,000 person-years of follow-up among females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI.
Prevalence of anifrolumab use
Time frame: 1 year
Within each country, the prevalence of anifrolumab use will be assessed within each calendar year interval of the follow-up period by calculating the number and percentage with prevalent anifrolumab use among all female patients of reproductive potential in a given calendar year (with 95% CI), as well as number of female patients of reproductive potential with prevalent anifrolumab use per 1,000,000 female patients of reproductive potential in a given calendar year (with 95% CI).
4 secondary outcomes
Baseline patient characteristics
Time frame: At anifrolumab treatment initiation (index date)
Baseline SLE treatment characteristics
Time frame: At anifrolumab treatment initiation (index date)
Anifrolumab treatment utilization patterns
Time frame: From anifrolumab treatment initiation (index date) up to 84 days post-initiation
Anifrolumab-exposed pregnancies
Time frame: From anifrolumab treatment initiation (index date) up to 93 days after date of last dose
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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
Zachary Bouck study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca.
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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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.
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?
Incidence of anifrolumab use (time frame: 1 year). 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 25 Feb 2026.