A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

• Register: EUCTR
• Last refreshed on: 9 January 2023
• Main ID: EUCTR2016-000625-39-BG
• Date of registration: 08/03/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus
• Scientific title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE
• Date of first enrolment: 17/05/2017
• Target sample size: 575
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000625-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Information Center
• Affiliation: AstraZeneca AB

• Name: Information Center
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
2. Adequate peripheral venous access
3. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
4. Meets the following TB criteria:
(a) Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
(b) Newly positive QFT-G test result for TB obtained at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must initiate treatment for latent TB within 30 days of randomisation, but prior to the second dose of investigational product administration (Visit 2/Week 4); OR
(c) Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. The subject must have been diagnosed with latent TB and must have documentation confirming completion of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
(d) Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
5. In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
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 383
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 192

Exclusion criteria:
1. Receipt of any of the following within the last 60 days:
(a) Azathioprine >200 mg/day
(b) Mycophenolate mofetil/mycophenolic acid >2.0 g/day
(c) Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
(d) Mizoribine >150 mg/day
2. Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
3. Receipt of any of the following:
(a) Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required
vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)
(b) Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
4. Active severe SLE-driven renal or neuropsychiatric disease
5. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
6. Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
7. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Current Sponsor code: MEDI 546
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): Rates of adverse events of special interest and serious adverse events from baseline of the Phase 3 pivotal Studies D3461C00004 or D3461C00005

Timepoint(s) of evaluation of this end point: 164 weeks

Main Objective: To characterise long-term safety and tolerability of intravenous anifrolumab.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

2016-000625-39-HU

D3461C00009

NCT02794285

Source(s) of Monetary Support

AstraZeneca AB

Ethics review

Status: Approved
Approval date: 27/04/2017
Contact:

Results

• Results available: Yes
• Date Posted: 04/01/2023
• Date Completed: 21/12/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000625-39/results