A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02962960
• Date of registration: 23/09/2016
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.
• Date of first enrolment: February 14, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02962960
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Hungary, Korea, Republic of, Poland, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18 through 70 years

2. Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling =4 of the 11
American College of Rheumatology (ACR) classification criteria with at least one
being:

- Positive antinuclear antibody (ANA) or

- Elevated anti-dsDNA antibodies or

- anti-Smith (anti-Sm) antibodies

3. Interferon high test result

4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score =
10

5. Currently receiving at least 1 of the following for treatment of SLE:

• Oral prednisone or equivalent of =40 mg/day for a minimum of 2 weeks prior to
signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks
prior to randomization

• Any of the following medications for at least 12 weeks prior to signing the ICF, and
at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine =200
mg/day (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii)
Mycophenolate mofetil =2 g/day or mycophenolic acid =1.44 g/day (iv) Oral,
subcutaneous (SC), or intramuscular methotrexate =25 mg/week (v) Mizoribine =150
mg/day

6. Must not have signs of active or latent tuberculosis (TB).

7. Must not be pregnant or breastfeeding.

Exclusion Criteria:

1. Active severe or unstable neuropsychiatric SLE

2. Active severe SLE-driven renal disease

3. Any severe herpes infection at any time

4. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.

5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition
predisposing for infection

6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing
of the ICF

7. History of cancer, apart from:

- Squamous or basal cell carcinoma of the skin if successfully treated.

- Cervical cancer in situ if successfully treated



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Anifrolumab

Drug: Placebo

Primary Outcome(s)

21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change) [Time Frame: Week 12]

Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab [Time Frame: Week 12]

Maximum Concentration of Anifrolumab in Serum After First Dose [Time Frame: Week 0]

21-gene Type 1 IFN Signature Score (Fold-change) [Time Frame: Week 12]

Secondary Outcome(s)

Number of Participants With Neutralizing Antibodies (nAb) [Time Frame: Baseline to Week 52]

Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) [Time Frame: Baseline to Week 60]

Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI) [Time Frame: Baseline to Week 52]

Value of Haematology Blood Tests to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Value of Haemoglobin Blood Test to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Number of Participants With Positive Hepatitis B Core Antibody Post-baseline. [Time Frame: Baseline to Week 60]

Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Change From Baseline for Physical Examination [Time Frame: Baseline to Week 60]

Change From Baseline for Vital Signs [Time Frame: Baseline to Week 60]

Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Value of Total Protein Urinalysis Test to Detect Change From Baseline [Time Frame: Baseline to Week 60]

Number of Participants With Antidrug Antibody (ADA) [Time Frame: Baseline to Week 52]

Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum) [Time Frame: Baseline to Week 60]

Change From Baseline for 12-lead ECG [Time Frame: Baseline to Week 52]

Secondary ID(s)

D3461C00008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02962960