Trial · NCT02446899
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446899, Phase 3, Completed, AstraZeneca; results first posted 2020-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus. Trials, record NCT02446899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02446899
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
- NCT number
- NCT02446899
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 373 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Active Systemic Lupus Erythematosus
- Interventions
- Anifrolumab, Placebo
- First posted
- 2015-05-18
- Last updated
- 2023-01-10
- Results first posted
- 2020-03-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 | Baseline; Week 52 | Composite endpoint BICLA was defined by meeting all of the following criteria: * Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of \>0 points in SLEDAI-2K * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment |
| Secondary | Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group | Baseline; Week 52 | Defined by meeting all of the following criteria: * Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline to \>0 points in SLEDAI-2K * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment |
| Secondary | Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day | Week 40; Week 52 | Maintained OCS reduction was defined by meeting all of the following criteria: * Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 * Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment |
| Secondary | Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10 | Baseline; Week 12 | 50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria: * Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment |
| Secondary | Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline | Baseline; Week 52 | 50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria: * Achieve ≥50% reduction from baseline in the number of swollen and tender joints, separately * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment |
| Secondary | Annualised Flare Rate Through 52 Weeks | Baseline to Week 52 | A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment. |
| Secondary | Number of Participants With One or More Adverse Events (AEs) | Baseline to end of study (Maximum of 60 weeks) | An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs. |
| Secondary | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | Baseline to end of study (Maximum of 60 weeks) | An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus \[SLE\]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction \[MI\], or cardiovascular death). AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
| Secondary | Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements | Baseline to end of study (Maximum of 60 weeks) | Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
| Secondary | Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests | Baseline to end of study (Maximum of 60 weeks) | Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 | Baseline; Week 52 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group | Baseline; Week 52 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug, with a high interferon (IFN) test result at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day | Week 40; Week 52 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug, who had a baseline OCS dose of ≥10 mg/day. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10 | Baseline; Week 12 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had a CLASI activity score of ≥10 at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline | Baseline; Week 52 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had ≥6 swollen and ≥6 tender joints at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annualised Flare Rate Through 52 Weeks | Baseline to Week 52 | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Annualized flare rate ratio | NUMBER |
| SECONDARY | Number of Participants With One or More Adverse Events (AEs) | Baseline to end of study (Maximum of 60 weeks) | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With One or More Adverse Events of Special Interest (AESIs) | Baseline to end of study (Maximum of 60 weeks) | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements | Baseline to end of study (Maximum of 60 weeks) | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests | Baseline to end of study (Maximum of 60 weeks) | Full Analysis Set: All participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 | Anifrolumab 300 mg | 86 | Participants | ||
| Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 | Placebo | 57 | Participants | ||
| Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group | Anifrolumab 300 mg | 72 | Participants | ||
| Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group | Placebo | 46 | Participants | ||
| Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day | Anifrolumab 300 mg | 45 | Participants | ||
| Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day | Placebo | 25 | Participants | ||
Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10 | Anifrolumab 300 mg | 24 | Participants | ||
Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10 | Placebo | 10 | Participants | ||
| Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline | Anifrolumab 300 mg | 30 | Participants | ||
| Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline | Placebo | 34 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anifrolumab 300 mg | 181 | |
| Overall Study | STARTED | Placebo | 184 | |
| Overall Study | Received Study Drug | Anifrolumab 300 mg | 180 | |
| Overall Study | Received Study Drug | Placebo | 182 | |
| Overall Study | COMPLETED | Anifrolumab 300 mg | 156 | |
| Overall Study | COMPLETED | Placebo | 136 | |
| Overall Study | NOT COMPLETED | Anifrolumab 300 mg | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 48 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Anifrolumab 300 mg | 7 | 180 | 7 |
| other | Nausea | Gastrointestinal disorders | Placebo | 10 | 182 | 11 |
| other | Bronchitis | Infections and infestations | Anifrolumab 300 mg | 23 | 180 | 31 |
| other | Bronchitis | Infections and infestations | Placebo | 8 | 182 | 8 |
| other | Herpes zoster | Infections and infestations | Anifrolumab 300 mg | 12 | 180 | 12 |
| other | Herpes zoster | Infections and infestations | Placebo | 3 | 182 | 3 |
| other | Nasopharyngitis | Infections and infestations | Anifrolumab 300 mg | 28 | 180 | 42 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 23 | 182 | 31 |
| other | Sinusitis | Infections and infestations | Anifrolumab 300 mg | 13 | 180 | 21 |
| other | Sinusitis | Infections and infestations | Placebo | 9 | 182 | 10 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anifrolumab 300 mg | 1 | 180 |
| Total, all-cause mortality | Placebo | 0 | 182 |
| Total, other adverse events | Anifrolumab 300 mg | 125 | 180 |
| Total, other adverse events | Placebo | 99 | 182 |
| Total, serious adverse events | Anifrolumab 300 mg | 16 | 180 |
| Total, serious adverse events | Placebo | 34 | 182 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anifrolumab 300 mg vs Placebo: Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline | Trial comparisons |
Anifrolumab 300 mg vs Placebo: Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants With One or More Adverse Events (AEs) | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: Number of Participants With One or More Adverse Events of Special Interest (AESIs) | Trial comparisons |
Anifrolumab 300 mg vs Placebo: Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10 | Trial comparisons |
| Anifrolumab 300 mg vs Placebo: deaths from any cause | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02446899
GET https://conductscience.org/api/trials/v1/NCT02446899/events?page=2