Trial Outcomes & Findings for A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects (NCT NCT02601625)

NCT ID: NCT02601625

Last Updated: 2019-02-26

Results Overview

To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
• Results posted on: 2019-02-26

Participant Flow

This study was conducted at the PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St. Baltimore, MD 21225 United States of America

All eligible participants underwent a screening period of a maximum of 28 days. During the treatment period all participants were asked to be the residents at the study site prior to the evening meal the night before dosing with anifrolumab or placebo (Day -1) until at least 48 hours after dosing; and were then discharged on the morning of Day 3.

Participant milestones

Measure	Anifrolumab 300 mg SC Injections Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo Randomized participants received Anifrolumab matching placebo.
Overall Study STARTED	6	6	6	12
Overall Study COMPLETED	6	6	5	11
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Measure	Anifrolumab 300 mg SC Injections Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo Randomized participants received Anifrolumab matching placebo.
Overall Study Lost to Follow-up	0	0	1	1

Baseline Characteristics

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

Baseline characteristics by cohort

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=12 Participants Randomized participants received Anifrolumab matching placebo.	Total n=30 Participants Total of all reporting groups
Age, Continuous	27.5 Years STANDARD_DEVIATION 6.89 • n=5 Participants	29.7 Years STANDARD_DEVIATION 7.97 • n=7 Participants	26.3 Years STANDARD_DEVIATION 6.65 • n=5 Participants	38.4 Years STANDARD_DEVIATION 12.26 • n=4 Participants	32.1 Years STANDARD_DEVIATION 10.62 • n=21 Participants
Sex/Gender, Customized Female	4 Count of participants n=5 Participants	1 Count of participants n=7 Participants	2 Count of participants n=5 Participants	4 Count of participants n=4 Participants	11 Count of participants n=21 Participants
Sex/Gender, Customized Male	2 Count of participants n=5 Participants	5 Count of participants n=7 Participants	4 Count of participants n=5 Participants	8 Count of participants n=4 Participants	19 Count of participants n=21 Participants

PRIMARY outcome

Timeframe: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days

Population: The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data

To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.

Up to 13 blood samples were collected in total.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab.	36.22 ug/mL Standard Deviation 11.63	82.44 ug/mL Standard Deviation 13.16	63.86 ug/mL Standard Deviation 20.45	—	—	—	—	—

PRIMARY outcome

Timeframe: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days

Population: The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data

To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously

Up to 13 blood samples were collected in total.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab	769.1 day*μg/mL Standard Deviation 336.9	902.9 day*μg/mL Standard Deviation 175.8	1639 day*μg/mL Standard Deviation 557.7	—	—	—	—	—

PRIMARY outcome

Timeframe: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days

Population: The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data

To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.

Up to 13 blood samples were collected in total.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab	784.6 day*μg/mL Standard Deviation 330.6	906.5 day*μg/mL Standard Deviation 174.9	1828 day*μg/mL Standard Deviation 679.8	—	—	—	—	—

PRIMARY outcome

Timeframe: From screening to final follow-up visit, up to 16 weeks

Population: The safety analysis set included all participants who received at least 1 dose of investigational medicinal product (IMP) (anifrolumab or placebo) and for whom any safety post-dose data were available.

To assess the safety and tolerability of single doses of anifrolumab

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=12 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC n=4 Participants Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC n=4 Participants Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV n=4 Participants Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants n=18 Participants Overall number of participants who received anifrolumab therapy.
Safety: Number of Participants With Adverse Events (AEs)	3 Participants	2 Participants	4 Participants	4 Participants	1 Participants	2 Participants	1 Participants	9 Participants

PRIMARY outcome

Timeframe: Immediately after dosing, at 10, 20 minutes and 1 hour after injection

Population: The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.

Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no pain" to 100 = "worst imaginable pain"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=4 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=4 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants Immediately after dosing	1.2 Millimeter Standard Deviation 2.21	0.0 Millimeter Standard Deviation 0.00	8.0 Millimeter Standard Deviation 13.69	0.0 Millimeter Standard Deviation 0.00	—	—	—	—
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants 10 min after injection	0.5 Millimeter Standard Deviation 0.63	0.0 Millimeter Standard Deviation 0.00	0.5 Millimeter Standard Deviation 1.00	0.0 Millimeter Standard Deviation 0.00	—	—	—	—
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants 20 min after injection	0.3 Millimeter Standard Deviation 0.42	0.0 Millimeter Standard Deviation 0.00	0.4 Millimeter Standard Deviation 0.75	0.3 Millimeter Standard Deviation 0.50	—	—	—	—
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants 1 hour after injection	0.2 Millimeter Standard Deviation 0.41	0.0 Millimeter Standard Deviation 0.00	0.3 Millimeter Standard Deviation 0.50	0.0 Millimeter Standard Deviation 0.00	—	—	—	—

PRIMARY outcome

Timeframe: Immediately after dosing, at 10, 20 minutes and 1 hour after injection

Population: The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.

Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no itching" to 100 = "worst imaginable itching"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=4 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=4 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants Immediately after dosing	1.3 Millimeter Standard Deviation 2.60	14.0 Millimeter Standard Deviation 20.29	1.3 Millimeter Standard Deviation 1.66	0.8 Millimeter Standard Deviation 0.96	—	—	—	—
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants 10 min after injection	0.7 Millimeter Standard Deviation 1.21	6.3 Millimeter Standard Deviation 14.56	0.6 Millimeter Standard Deviation 1.25	0.0 Millimeter Standard Deviation 0.00	—	—	—	—
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants 20 min after injection	0.3 Millimeter Standard Deviation 0.52	1.5 Millimeter Standard Deviation 3.67	0.5 Millimeter Standard Deviation 1.00	0.3 Millimeter Standard Deviation 0.50	—	—	—	—
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants 1 hour after injection	0.1 Millimeter Standard Deviation 0.20	0.0 Millimeter Standard Deviation 0.00	0.4 Millimeter Standard Deviation 0.75	0.0 Millimeter Standard Deviation 0.00	—	—	—	—

PRIMARY outcome

Timeframe: Immediately after dosing, at 10, 20 minutes and 1 hour after injection

Population: The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.

Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=4 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=4 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants Immediately after dosing	0.3 Millimeter Standard Deviation 0.42	17.0 Millimeter Standard Deviation 19.75	11.5 Millimeter Standard Deviation 14.62	20.0 Millimeter Standard Deviation 13.54	—	—	—	—
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants 10 minutes after injection	2.0 Millimeter Standard Deviation 4.18	17.5 Millimeter Standard Deviation 21.39	5.1 Millimeter Standard Deviation 9.59	18.0 Millimeter Standard Deviation 14.99	—	—	—	—
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants 20 minute after injection	2.7 Millimeter Standard Deviation 4.14	16.6 Millimeter Standard Deviation 20.81	5.5 Millimeter Standard Deviation 9.11	26.0 Millimeter Standard Deviation 18.55	—	—	—	—
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants 1 hour after injection	0.3 Millimeter Standard Deviation 0.52	2.5 Millimeter Standard Deviation 6.12	0.3 Millimeter Standard Deviation 0.50	10.0 Millimeter Standard Deviation 14.14	—	—	—	—

PRIMARY outcome

Timeframe: Immediately after dosing, at 10, 20 minutes and 1 hour after injection

Population: The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.

Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=4 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=4 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants Immediately after dosing	4.2 Millimeter Standard Deviation 10.21	22.5 Millimeter Standard Deviation 13.69	0.0 Millimeter Standard Deviation 0.00	12.5 Millimeter Standard Deviation 15.00	—	—	—	—
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants 10 minutes after injection	0.8 Millimeter Standard Deviation 2.04	17.3 Millimeter Standard Deviation 12.39	0.0 Millimeter Standard Deviation 0.00	16.5 Millimeter Standard Deviation 19.21	—	—	—	—
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants 20 minute after injection	0.1 Millimeter Standard Deviation 0.20	14.1 Millimeter Standard Deviation 11.41	0.1 Millimeter Standard Deviation 0.25	8.0 Millimeter Standard Deviation 16.00	—	—	—	—
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants 1 hour after injection	0.0 Millimeter Standard Deviation 0.00	11.7 Millimeter Standard Deviation 13.29	0.0 Millimeter Standard Deviation 0.00	12.5 Millimeter Standard Deviation 25.00	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and at Days 5 and Day 29, up to 85 days

Population: The safety analysis set included all subjects who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.

Immunogenicity was assessed in all groups by the presence or absence of ADA, which was determined in serum samples using validated bioanalytical methods. The reported results are based on the confirmatory assay (positive/negative) of the ADA. The number of participants with positive, negative and missing results are reported for each time point using the safety analysis set.

Outcome measures

Measure	Anifrolumab 300 mg SC Injections n=6 Participants Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 Participants Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Anifrolumab 600 mg SC Infusion n=6 Participants Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=12 Participants Randomized participants received Anifrolumab matching placebo.	Placebo 300 mg Anifrolumab SC n=30 Participants Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 600 mg Anifrolumab SC Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump.	Placebo 300 mg Anifrolumab IV Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes.	All Anifrolumab Participants Overall number of participants who received anifrolumab therapy.
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 1, pre-dose (positive)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 1, pre-dose (negative)	6 Participants	6 Participants	6 Participants	12 Participants	30 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 1, pre-dose (missing)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 5 (positive)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 5 (negative)	6 Participants	6 Participants	6 Participants	12 Participants	30 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 5 (missing)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 29 (positive)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 29 (negative)	6 Participants	6 Participants	5 Participants	11 Participants	28 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 29 (missing)	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 85 (positive)	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 85 (negative)	6 Participants	5 Participants	5 Participants	11 Participants	27 Participants	—	—	—
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). Day 85 (missing)	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	—	—	—

Adverse Events

Anifrolumab 300 mg SC Injections

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Anifrolumab 300 mg IV Infusion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo 300 mg Anifrolumab SC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo 300 mg IV Infusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo 600 mg Anifrolumab (SC)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Anifrolumab 600 mg SC Infusion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

All Anifrolumab Subjects

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Anifrolumab 300 mg SC Injections n=6 participants at risk Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Anifrolumab 300 mg IV Infusion n=6 participants at risk Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1	Placebo 300 mg Anifrolumab SC n=4 participants at risk Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1.	Placebo 300 mg IV Infusion n=4 participants at risk Participants received 300 mg single dose placebo delivered as an IV infusion over 30 minutes on Day 1.	Placebo 600 mg Anifrolumab (SC) n=4 participants at risk Participants received 600 mg single dose placebo delivered as 4 mL SC by infusion pump on Day 1.	Anifrolumab 600 mg SC Infusion n=6 participants at risk Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1	Pooled Placebo n=12 participants at risk Randomized participants received Anifrolumab matching placebo.	All Anifrolumab Subjects n=18 participants at risk Overall number of participants who received anifrolumab therapy
Infections and infestations Upper respiratory tract infection	33.3% 2/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 3/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Infections and infestations Tooth abscess	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Infections and infestations Oral herpes	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	25.0% 1/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	8.3% 1/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Infections and infestations Tinea pedis	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
General disorders Chest discomfort	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
General disorders Infusion site pruritus	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
General disorders Peripheral swelling	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	25.0% 1/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	8.3% 1/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
General disorders Vessel puncture site bruise	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	33.3% 2/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	11.1% 2/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Immune system disorders Food allergy	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Nervous system disorders Headache	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	25.0% 1/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	8.3% 1/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Nervous system disorders Somnolence	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	16.7% 1/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	5.6% 1/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Reproductive system and breast disorders Menstrual disorder	25.0% 1/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/1 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/1 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/2 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/1 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/2 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	14.3% 1/7 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	25.0% 1/4 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/6 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	8.3% 1/12 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.	0.00% 0/18 • From screening to final follow-up visit, up to 16 weeks An adverse event (AE) is any 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.

Additional Information

Anifrolumab Global Clinical Leader

AstraZeneca AB

Phone: +46317761000

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee All of the study information and data collected during the study are confidential and the property of AstraZeneca. After completion of the study, the investigator may prepare a joint publication with AstraZeneca. The investigator must undertake not to submit any part of the individual data from this study for publication without prior consent of AstraZeneca at a mutually agreed time.
• Publication restrictions are in place

Restriction type: OTHER