The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2016-003246-93-HU
• Date of registration: 19/10/2016
• Prospective Registration: Yes
• Primary sponsor: Astrazeneca AB
• Public title: The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.
• 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: 06/12/2016
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003246-93
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Sponsor will be unblinded after all patients complete week 12 visit.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Hungary, Korea, Republic of, Poland, United States

Contacts

• Name: Clinical Trial Transparency
• Affiliation: AstraZeneca

• Name: Clinical Trial Transparency
• Affiliation: AstraZeneca

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 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. 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 ICFand with stable dosefor 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 TB.
7. Must not be pregnant or breastfeeding



Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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. HBV, 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): • Anifrolumab concentration and PK parameters, e.g., maximum concentration (Cmax) after first IP dose and trough concentration (Ctrough) after subsequent dosing. Additional PK parameters may be determined where appropriate.
• 21-gene type I IFN signature score and neutralization ratio (relative to baseline)

Main Objective: To characterize the pharmacokinetics and pharmacodynamics of anifrolumab.

Secondary Objective: 1. To characterize the safety and tolerability anifrolumab
2. To characterize the immunogenicity of anifrolumab

Timepoint(s) of evaluation of this end point: 12 Weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary end point(s): Safety and tolerability variables including:
• Adverse events (AEs) and serious adverse events (SAEs)
• Adverse events of special interest (AESIs) including herpes zoster, influenza, opportunistic infections, tuberculosis (TB), malignancies, non-SLE related vasculitis, anaphylaxis, and major adverse cardiovascular events (MACE)
• Laboratory variables
• Physical examinations
• Vital signs
• ECG
Immunogenicity as assessed by measurement of anti-drug antibodies (ADA).

Secondary ID(s)

D3461C00008

Source(s) of Monetary Support

AstraZeneca

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 07/09/2019
• Date Completed: 17/12/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003246-93/results