Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

NCT05383677 | Unknown Phase 2 FDA Drug

• 2 other identifiers: ESR-21-212842022-000609-28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response

  The CRESS is a recently developed composite endpoint which consists of five clinically relevant items for pSS: a systemic disease activity, patient-reported symptoms, tear gland, salivary gland and serology item. A CRESS responder is someone who reached response on at least three out of five items (Arends et al., https://doi.org/10.1016/S2665-9913(21)00122-3)

  Week 24

Secondary Outcomes (27)

• Safety (adverse events and tolerability)

  Weeks 0, 4, 8, 12, 16, 20 and 24

• Total CRESS response

  Week 12

• ClinESSDAI

  Weeks 0, 8, 12, 20, 24

• ESSPRI

  Weeks 0, 8, 12, 20, 24

• Schirmer's test

  Weeks 0, 12, 24

Study Arms (2)

Anifrolumab

ACTIVE COMPARATOR

20 patients will receive anifrolumab treatment

Drug: Anifrolumab

Placebo

PLACEBO COMPARATOR

10 patients will receive placebo treatment

Drug: Placebo

Interventions

Anifrolumab DRUG

Anifrolumab 300 mg will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.

Also known as: Saphnelo

Anifrolumab

Placebo DRUG

Placebo will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Female or male aged ≥18 years
• Disease duration (time since diagnosis) ≤10 years. In case of pediatric-onset pSS a disease duration of ≤15 years is allowed if there is residual gland function (UWS≥0.01 or SWS≥0.1 ml/min).
• Fulfilment of 2016 ACR-EULAR classification criteria for pSS (which includes focus score ≥1 in salivary gland biopsy and/or anti-SSA/Ro positivity), based on previous diagnostic examinations
• Presence of anti-SSA antibodies
• Willingness to undergo a repeated parotid gland biopsy at baseline and 24 weeks after start treatment. If a recent parotid gland biopsy (within ≤1 year before the baseline visit) is available, and enough material of this parotid gland biopsy is available, this biopsy can be used as baseline sample.
• Use of reliable method of contraception for participants of reproductive potential.
• Vaccinated against COVID-19 (at least two COVID-19 vaccinations) or previous confirmed COVID-19 infection (from which the patient is recovered) in combination with at least one COVID-19 vaccination or a previous confirmed COVID-19 infection (from which the patients has recovered) in combination with a positive anti-SARS-CoV-2 antibody test.

You may not qualify if:

• Presence of any other connective tissue disease
• Positive pregnancy test (urinary HCG) at screening or breast-feeding
• History of alcohol or drug abuse
• History of malignancy or with a current suspicion for cancer, apart from local MALT lymphoma, squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months prior to week 0 or cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to week 0.
• Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of HIV which will be tested during screening.
• History of chronic or recurrent serious infections. (e.g. chronic pyelonephritis, osteomyelitis or bronchiectasis).
• Subjects with serious bacterial infections within the last 3 months, unless treated and resolved with antibiotics.
• Opportunistic infection requiring hospitilization or IV antimicrobial treatment within 3 years of randomization
• Any infection requiring hospitalization or treatment with IV anti-infective medications not completed at least 4 weeks prior to signing the ICF.
• Subjects with herpes zoster that resolved less than 12 weeks before potential enrollment or any severe case of herpes zoster in a subjects history, including, but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes involving the retina (ever).
• Any clinical cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.
• Any history of severe COVID-19 infection (e.g. requiring hospitalization, ICU care or assisted ventilation) or any prior COVID-19 infection with unresolved sequelae. Any acute COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 3 months prior to screening.
• Subjects at risk for TB. Specifically excluded from this study will be subjects with a history of active TB; current clinical, radiographic, or laboratory evidence of active TB, which will be tested during screening; history of latent TB, with the exception of latent TB with documented completion of appropriate treatment.
• Subjects who are positive for hepatitis B surface antigen, which will be tested during screening.
• Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay, which will be tested during screening.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• AstraZeneca: collaborator

Study Sites (1)

University Medical Centre Groningen

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hendrika Bootsma

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hendrika Bootsma

CONTACT

+315036129456; h.bootsma@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 20, 2022
• Study Start: October 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

NL (1)