Clinical trial • Phase III • Immunology

ANIFROLUMAB for Systemic lupus erythematosus | Moderate-to-severe systemic lupus erythematosus

Phase III trial of ANIFROLUMAB for Systemic lupus erythematosus | Moderate-to-severe systemic lupus erythematosus.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus | Moderate-to-severe systemic lupus erythematosus
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
28-03-2024
First CTIS Authorization Date
06-05-2024

Trial design

Randomised, placebo (matching subcutaneous injection); dose and schedule not specified in the provided data-controlled Phase III trial in Spain, Germany, Hungary and others.

Randomised
Yes
Comparator
Placebo (matching subcutaneous injection); dose and schedule not specified in the provided data
Target Sample Size
280
Trial Duration For Participant
364

Eligibility

Recruits 280 paediatric patients.

Pregnancy Exclusion
Lactating, breastfeeding or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 Weeks following last dose of study intervention
Vulnerable Population
The trial record indicates a vulnerable population selection (isVulnerablePopulationSelected: true) and explicitly includes paediatric or adult SLE in the inclusion criteria. Informed Consent Forms (ICFs) and multiple subject information / ICF documents (in various languages) are listed. The provided excerpts do not include explicit text describing parental consent or minor assent procedures, so no specific assent/parental consent wording is available in the supplied data.

Inclusion criteria

  • {"criterion_text":"- Patients who have a diagnosis of paediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 Weeks prior to signing the ICF"}
  • {"criterion_text":"- Women of childbearing potential must have a negative urine pregnancy test at randomisation (Day 1), prior to administration of study intervention"}
  • {"criterion_text":"- Women of non-childbearing potential must be postmenopausal or have been surgically sterilised (for example: bilateral oophorectomy, or complete hysterectomy), which should be documented in the patient’s medical records"}
  • {"criterion_text":"- Age-specific requirements may apply for a postmenopausal state"}
  • {"criterion_text":"- Females of childbearing potential must use 1 highly effective methods of contraception, plus a male condom, from Screening until 16 Weeks after the final dose of study intervention, unless the patient is surgically sterile (eg, bilateral oophorectomy, tubal ligation, or complete hysterectomy), has a sterile/non-fertile male partner, is at least 12 months postmenopausal, or practices sustained abstinence consistent with the patient’s lifestyle"}
  • {"criterion_text":"- Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening (Pap smear or human papilloma virus [HPV] tests as per local guidelines) with a normal test result within 2 years prior to randomisation. Any abnormal cervical cancer screening result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility"}
  • {"criterion_text":"- Females aged < 25 years, who have never been sexually active or have well-documented HPV vaccination records may not require a cervical cancer screening test."}
  • {"criterion_text":"- To be eligible a patient must have a total SLEDAI-2K ≥ 6 points, with ≥ 4 points coming from clinical components (“Clinical” SLEDAI-2K”) at Screening (for additional details see a,b,c,d)"}
  • {"criterion_text":"- At Screening, BILAG-2004 with at least 1 of the following as confirmed by Disease Activity Central Review Team: (a) BILAG-2004 level A disease in ≥ 1 organ system (b) BILAG-2004 level B disease in ≥ 2 organ systems"}
  • {"criterion_text":"- Physician’s Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening"}
  • {"criterion_text":"- Antinuclear antibody, and/or Anti-dsDNA and/or anti-Smith positive at Screening."}
  • {"criterion_text":"- Must be on stable background standard therapy with antimalarials and/or immunosuppressant(s) and glucocorticoids alone or in combination"}
  • {"criterion_text":"- All fertile males who are sexually active must use condom from Day 1 until at least 16 Weeks after receipt of the final dose of study intervention. It is strongly recommended that the female partner of a male patient also use an effective method of contraception from Table 9 throughout this period."}
  • {"criterion_text":"- Male patients must not donate sperm during the course of the study and for 16 Weeks after the last dose of the study intervention"}
  • {"criterion_text":"- Negative serum β-human chorionic gonadotropin (β-hCG) test at Screening (females of childbearing potential only)."}

Exclusion criteria

  • {"criterion_text":"- Active severe or unstable neuropsychiatric SLE"}
  • {"criterion_text":"- Active severe SLE-driven renal disease"}
  • {"criterion_text":"- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening"}
  • {"criterion_text":"- Any severe case herpes zoster infection at any time prior to Week 0 (Day 1)"}
  • {"criterion_text":"- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization"}
  • {"criterion_text":"- History of cancer, apart from: a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1) or b. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1)"}
  • {"criterion_text":"- Any history of severe COVID-19 infection eg, prolonged hospitalisation [hospitalisation for observational purposes is not exclusionary] or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae. Any mild/asymptomatic COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 6 Weeks prior to first dosing"}
  • {"criterion_text":"- Lactating, breastfeeding or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 Weeks following last dose of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52","definition_or_measurement_approach":"Defined as a composite binary response (BICLA) by meeting all criteria referenced in the protocol (see protocol pages 25 and 52)"}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients who are BICLA responders at Week 52 and have maintained low (or reduced) OSC use through Week 52 maintained low (or reduced) OSC use is defined as per protocol pages 26 and 52.","definition_or_measurement_approach":"Proportion of patients who are BICLA responders at Week 52 and have maintained low (or reduced) oral corticosteroid (OCS) use, with 'maintained low (or reduced) OCS use' defined in protocol pages 26 and 52"}
  • {"endpoint_text":"- The time from first dose of study intervention during the Double-Blind Study Period to first BICLA response sustained through Week 52","definition_or_measurement_approach":"Time-to-event measured from first dose in double-blind period to first BICLA response that is sustained through Week 52"}
  • {"endpoint_text":"- Time to flare through Week 52 where flare is defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG 2004 B items compared to the previous visit","definition_or_measurement_approach":"Time-to-flare measured through Week 52; flare defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items compared to previous visit"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
280
Recruitment Window Months
65
Consent Approach
Informed consent is required (references to ICF and multiple subject information and informed consent form documents are listed). Multiple language ICFs and patient-facing information documents are provided (EN, DE, BG, PL, HU, ES). Specific parental consent or minor assent text is not present in the supplied JSON excerpts, though paediatric patients are included in eligibility and ICF documents are available.

Methods

  • Banner advertisements (K2_Banner Ads) — recruitment banners referenced in recruitment documents (Germany-specific version present)
  • Online advertisements, social media and clinical trial posts (K2_Online Advertisements_Social Media and Clinical Trial Posts)
  • Site posters (K2_Site Poster)
  • Doctor-to-patient letters (L2_Dr-to-Patient Letter)
  • Patient brochures and patient study guides (L2_Patient Brochure; L2_Patient Study Guide)
  • eCOA handheld digital subject materials and training (multiple D4 patient-facing eCOA Handheld documents) to support remote data capture and patient engagement

Geography

Total Number Of Sites
43
Total Number Of Participants
96

Spain

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
325
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumotology
Contact Person Name
Josefina Cortes Hernandez
Contact Person Email
fina.cortes@vhir.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Physican
Contact Person Name
Jorge Juan Gonzalez Martin
Contact Person Email
jjgonzalez@hmhospitales.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Rheumatology
Contact Person Name
Antonio Mera Varela
Contact Person Email
antonio.mera.varela@sergas.es
Site Name
Hospital Del Mar
Department Name
Rheumatology
Contact Person Name
Tarek Carlos Salman Monte
Contact Person Email
tareto4@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Rheumatology
Contact Person Name
Jose Andres Roman Ivorra
Contact Person Email
roman_jan@gva.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Rheumatology
Contact Person Name
Juan Miguel Sanchez Burson
Contact Person Email
reujsb@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Internal Medicine
Contact Person Name
Gerard Espinosa Garriga
Contact Person Email
gespino@clinic.cat
Site Name
Hospital Universitario Infanta Sofía
Department Name
Rheumatology
Contact Person Name
Santiago Muñoz Fernandez

Germany

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
07-03-2025
Processing Time Days
326
Number Of Sites
7
Number Of Participants
9

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik fuer Dermatol., Venerol., Allergologie
Contact Person Name
Margitta Worm
Contact Person Email
margitta.worm@charite.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Rheumatologie und klinische Immunologie
Contact Person Name
Thomas Doerner
Contact Person Email
thomas.doerner@charite.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I fuer Innere Medizin
Contact Person Name
Philipp Koehler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik fuer Immunologie und Rheumatologie
Contact Person Name
Torsten Witte
Contact Person Email
witte.torsten@mh-hannover.de
Site Name
Staedtisches Klinikum Dresden
Department Name
I. medizinische Klinik - Rheumatologie
Contact Person Name
Leonore Unger
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin II
Contact Person Name
Joerg Henes
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik u. Poliklinik f. Gastroenterologie Rheumat.
Contact Person Name
Ulf Wagner

Hungary

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
12-03-2025
Processing Time Days
331
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Vital Medical Center
Department Name
-
Contact Person Name
Edit Drescher
Contact Person Email
drescher@invitel.hu
Site Name
Budai Irgalmasrendi Korhaz Nonprofit Kft.
Department Name
Klinikai Farmakológia
Contact Person Name
Zsófia Kiss
Contact Person Email
drkisszsofia@gmail.com
Site Name
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Department Name
-
Contact Person Name
Tünde Varga
Contact Person Email
vargatundedr1@gmail.com
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Belgyogyaszat - Immunologia
Contact Person Name
János Kádár
Contact Person Email
drkadarj@t-online.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Infektologia es Hepatologia
Contact Person Name
Tibor Martyin
Contact Person Email
martyintibor@freemail.hu

Bulgaria

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
351
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
UMHAT Sofiamed OOD
Department Name
Department of Rheumatology
Contact Person Name
Natalia Marinova
Contact Person Email
natalimarinova1967@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Rheumatology
Contact Person Name
Rumen Stoilov
Contact Person Email
rmstoilov@abv.bg
Site Name
Medical Center Rodopimed EOOD
Contact Person Name
Ginka Nikolova
Contact Person Email
gin.zikova@gmail.com
Site Name
Medical Center Excelsior OOD
Contact Person Name
Tsvetanka Petranova
Contact Person Email
dr_petranova@yahoo.com
Site Name
DCC 1 Sevlievo EOOD
Contact Person Name
Dimitar Nikolov
Contact Person Email
dr.dimitar.nikolov@gmail.com
Site Name
University Multiprofessional Hospital For Active Treatment Plovdiv AD
Department Name
Rheumatology department
Contact Person Name
Ivan Goranov
Contact Person Email
goranov_ivan@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Department of Rheumatology
Contact Person Name
Rasho Rashkov
Contact Person Email
proff_rashkov@yahoo.com
Site Name
Military Medical Academy
Department Name
Department of Rheumatology
Contact Person Name
Boycho Oparanov
Contact Person Email
oparanov@abv.bg
Site Name
Synexus Bulgaria EOOD
Contact Person Name
Daniela Bichovska
Contact Person Email
ivdan@abv.bg

Poland

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
13-03-2025
Processing Time Days
332
Number Of Sites
14
Number Of Participants
40

Sites

Site Name
Sląskie Centrum Reumatologii Ortopedii I Rehabilitacji W Ustroniu Sp. z o.o.
Department Name
CENTRUM REUMATOLOGII, ORTOPEDII I REHABILITACJI Sp z o.o.
Contact Person Name
Anita Tokarczyk-Knapik
Contact Person Email
magopsowicz@reumatologiczny.pl
Site Name
Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki
Contact Person Name
Marek Zawadzki
Contact Person Email
mareklek.9@wp.pl
Site Name
Prywatna Praktyka Lekarska Prof Dr Hab Med Paweł Hrycaj
Contact Person Name
Paweł Hrycaj
Contact Person Email
pawel.hrycaj@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Katarzyna Romanowska-Próchnicka
Contact Person Email
marta.jeka@medicover.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Magdalena Celinska-Lowenhoff
Contact Person Email
trials@plejady.com.pl
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Katowice
Contact Person Name
Tomasz Dziewit
Contact Person Email
tdziewit@poczta.onet.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grażyna Pulka
Contact Person Email
allmedpl@gmai.com
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Mariusz Korkosz
Contact Person Email
mcm.mariusz.korkosz@mp.pl
Site Name
FutureMeds Wrocław
Contact Person Name
Ewa Krecipro-Nizińska
Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
Contact Person Name
Robert Zwolak
Contact Person Email
zwolakr@wp.pl
Site Name
Somed Cr Sp. z o.o. sp.k.
Contact Person Name
Anna Strzelecka
Contact Person Email
somedcr@somed.pl
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia - Centrum Medyczne Nowa Sól
Contact Person Name
Małgorzata Miakisz
Contact Person Email
ncm@twojaprzychodnia.com
Site Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
Contact Person Name
Maria Rell-Bakalarska
Contact Person Email
rell-bakalarska@wp.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Contact Person Name
Anna Zubrzycka-Sienkiewicz
Contact Person Email
k.groman@reumatika.pl

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
IQVIA Limited
Responsibilities
Sponsor duties codes: 1,10,11,12,2,7,8,9; contact email: eu_clinical_trials_information@iqvia.com; phone: 441184506016

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,2,7,8,9; contact email: eu_clinical_trials_information@iqvia.com; phone: 441184506016","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Anifrolumab
Active Substance
ANIFROLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (SmPC available)
Combination Treatment
Yes

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