ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Written informed consent.
- Female or male aged >= 18 years.
- Disease duration <= 10 years.
- Fulfillment of the 2016 ACR/EULAR classification criteria for primary
Sjögren's syndrome.
- ESSDAI >=5 and/or ESSPRI >=5. ESSDAI >=5 implicates a moderate to high
systemic disease activity and ESSPRI >=5 implicates that the patient-reported
symptom state is unacceptable. At least 50% of patients need to fulfil the
ESSDAI >=5 criterion. Inclusion of patients with low ESSDAI (<5) should be
discontinued when 50% have a low ESSDAI.
- Willingness to undergo a repeated biopsy. Baseline biopsy <=1 year before
inclusion and follow-up biopsy 24 weeks after start treatment.
- Use of reliable method of contraception for participants of reproductive
potential.
- Fully vaccinated against SARS-CoV-2, based on the current vaccine
recommendations for immunocompromised patients.
- Weight of >= 40 kg.

Exclusion Criteria

- Presence of any other connective tissue disease.
- Positive pregnancy test at screening or breastfeeding.
- 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 years
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.
- Subjects who have received any live or attenuated vaccines within 8 weeks
prior to signing the ICF.
- Blood transfusion or receipt of blood products within 4 weeks prior to
signing the ICF.
- Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal,
hematological or neurological conditions, chronic or latent infectious diseases
or immune deficiency which places the patient at an unacceptable risk for
participation in this study.
- Preceding treatment with biological DMARDs, including abatacept, anti-TNF or
other monoclonal antibodies within 6 months, and rituximab within 12 months
from baseline.
- Use of high-dose prednisone, less than 2 weeks before inclusion. Stable low
dose (<= 10 mg) is allowed.
- Use of hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine,
azathioprine, MMF and leflunomide less than 3 months ago.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The selected primary outcome measure is the Composite of Relevant Endpoints for<br /><br>Sjögren*s Syndrome (CRESS) response at week 24. The CRESS is a recently<br /><br>developed composite endpoint which consists of five clinically relevant items<br /><br>for pSS: a systemic disease activity, patient-reported symptoms, tear gland,<br /><br>salivary gland and serology item. A CRESS responder is someone who reached<br /><br>response on at least three out of five items.</p><br>

Secondary Outcome Measures

Name	Time	Method

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