Systemic Lupus ErythematosusPhase 1NCT05001698
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 3 sites in China.
Trial summary
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesChina
- Study dates
- 27 Jul 2021to 2 Jun 2022
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60 years.
- Body weight ≥ 40 kg.
- Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
- Must be receiving at least one of the following SOC regimens at screening:
- oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for > 2 weeks;
- Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required;
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- Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
- At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
- At screening, SLEDAI-2K score ≥ 6 points.
- Chest imaging shows no clinically significant abnormalities (unless due to SLE).
- No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
- All participants should use effective contraception methods as protocol requests.
Who cannot join
- History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
- History or evidence of suicidal ideation or suicidal behavior.
- History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
- History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
- History of immunodeficient condition, HIV positive included.
- Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable.
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- History of severe case of herpes zoster.
- Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
- Acute COVID-19 infection or history of severe COVID-19.
- History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
- Women participants with abnormal pap smear results.
- Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor.
- Known history of allergy to any component of the IP formulation or protein related products.
- Receipt of any of the following:
- Intramuscular or IV glucocorticosteroids within 6 weeks;
- Any live or attenuated vaccine within 8 weeks;
- Any restricted medication listed in protocol;
- Blood transfusion within 4 weeks.
- Certain laboratory test results requirements.
- Concurrent enrolment in another clinical study.
- History or current alcohol, drug or chemical abuse within 1 year.
- Major surgery within 8 weeks or planned elective major surgery.
- Blood donation or blood loss more than 400 mL within 3 months.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Research Site
Nantong, 226001
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
About this study
Official title: A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE)
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
Read the detailed description
This is a Phase I, open-label, single-arm, multiple-dose study to evaluate the pharmacokinetics (PK), pharmacodynamics(PD), safety and tolerability profile of intravenously administered anifrolumab in Chinese participants with active SLE despite receiving standard of care (SOC).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anifrolumab
- Keywords
- systemic lupus erythematosus, SLE, pharmacokinetic, 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
intravenous infusion (IV)
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | All eligible participants will receive anifrolumab via intravenous (IV) infusion pump. Receives: Biological: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum observed plasma concentration (Tmax) of anifrolumab.
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Measured: Day 1 to Day 141
Maximum observed plasma concentration (Cmax) of anifrolumab.
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Measured: Day 1 to Day 141
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of anifrolumab.
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Measured: Day 1 to Day 141
Pre-dose trough concentration (Ctrough) of anifrolumab.
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Measured: Day 1 to Day 141
The volume of plasma cleared of drug per unit time (CL) of anifrolumab.
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Measured: Day 1 to Day 141
Secondary outcomes (5)
Incidence of adverse events
To characterise the safety and tolerability of anifrolumab via IV infusion.
Measured: From Screening, Day 1 to Day 141
Incidence of abnormal vital signs
To characterise the safety and tolerability of anifrolumab via IV infusion.
Measured: From Screening, Day 1 to Day 141
Incidence of abnormal laboratory parameters
To characterise the safety and tolerability of anifrolumab via IV infusion.
Measured: Day 29, 57, 85, 113, 141
Anti-drug antibodies (ADA)
To characterise the immunogenicity of anifrolumab via IV infusion.
Measured: Day 1, 85, 113, 141
21-gene Type I interferon PD signature
To evaluate the IFN level change from baseline after administration of anifrolumab.
Measured: Screening, Day 29, 85, 113, 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start27 Jul 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001698
- Sponsor's protocol ID
- D3468C00002
- Status last verified
- Aug 2022
- First submitted
- 30 Jun 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT05001698
- Acronym / sponsor ID
- D3468C00002
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic lupus erythematosus, SLE, pharmacokinetic, anifrolumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 12 Aug 2021 (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.
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
Detailed description
This is a Phase I, open-label, single-arm, multiple-dose study to evaluate the pharmacokinetics (PK), pharmacodynamics(PD), safety and tolerability profile of intravenously administered anifrolumab in Chinese participants with active SLE despite receiving standard of care (SOC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Biological: AnifrolumabAll eligible participants will receive anifrolumab via intravenous (IV) infusion pump. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Aged 18 to 60 years.
- Body weight ≥ 40 kg.
- Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
- Must be receiving at least one of the following SOC regimens at screening:
- At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
Key exclusion criteria (23 listed)
- History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
- History or evidence of suicidal ideation or suicidal behavior.
- History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
- History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
- History of immunodeficient condition, HIV positive included.
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 |
|---|---|---|
| Anifrolumabintravenous infusion (IV) | Biological | Anifrolumab |
Primary outcome
Time to maximum observed plasma concentration (Tmax) of anifrolumab.
Time frame: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Maximum observed plasma concentration (Cmax) of anifrolumab.
Time frame: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of anifrolumab.
Time frame: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Pre-dose trough concentration (Ctrough) of anifrolumab.
Time frame: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
The volume of plasma cleared of drug per unit time (CL) of anifrolumab.
Time frame: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
5 secondary outcomes
Incidence of adverse events
Time frame: From Screening, Day 1 to Day 141
Incidence of abnormal vital signs
Time frame: From Screening, Day 1 to Day 141
Incidence of abnormal laboratory parameters
Time frame: Day 29, 57, 85, 113, 141
Anti-drug antibodies (ADA)
Time frame: Day 1, 85, 113, 141
21-gene Type I interferon PD signature
Time frame: Screening, Day 29, 85, 113, 141
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anifrolumab in people with Systemic Lupus Erythematosus, run by AstraZeneca at 3 sites in China.
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 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to maximum observed plasma concentration (Tmax) of anifrolumab. (time frame: Day 1 to Day 141). The study lists 5 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 18 Aug 2022.