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)

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) - ANISE-II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51816

Enrollment

Registered

2022-04-19

Start date

2022-10-09

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's syndrome

Interventions

Anifrolumab vs. placebo treatment. Anifrolumab 300 mg will be administered in intravenous infusions, once per 4 weeks, for a total treatment duration of 24 weeks. In total, participants will have 6

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent. - Female or male aged >= 18 years. - Disease duration =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 (= 40 kg.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The selected primary outcome measure is the Composite of Relevant Endpoints for Sjögren*s Syndrome (CRESS) response at week 24. 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.	—

Measure

Time frame

The selected primary outcome measure is the Composite of Relevant Endpoints for Sjögren*s Syndrome (CRESS) response at week 24. 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.

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Secondary

Measure	Time frame
1. Safety (adverse events and tolerability) of anifrolumab by monitoring serious adverse events (SAE) and AE, treatment discontinuation related to SAE and AE, and lab abnormalities at weeks 0, 4, 8, 12, 16, 20 and 24. 2. Total CRESS response at week 12 3. Individual CRESS items (continuous): Clinical EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (weeks 0, 8, 12, 20, 24), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (weeks 0, 8, 12, 20, 24), Schirmer*s test (weeks 0, 12, 24), Ocular Staining Score (OSS) (weeks 0, 12, 24), unstimulated whole salivary flow (UWS) (weeks 0, 12, 24), Salivary gland ultrasonography (SGUS) (Hocevar score) (weeks 0, 12, 24), rheumatoid factor (RF) and total IgG concentration in blood (weeks 0, 8, 12, 20, 24). 4. ESSDAI (continuous) (weeks 0, 8, 12, 20, 24) 5. The (Clin)ESSDAI minimal clinically important improvement (MCII, defined as decrease of >=3 points) and low disease activity (LDA, defined as score	—

Measure

Time frame

1. Safety (adverse events and tolerability) of anifrolumab by monitoring serious adverse events (SAE) and AE, treatment discontinuation related to SAE and AE, and lab abnormalities at weeks 0, 4, 8, 12, 16, 20 and 24. 2. Total CRESS response at week 12 3. Individual CRESS items (continuous): Clinical EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (weeks 0, 8, 12, 20, 24), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (weeks 0, 8, 12, 20, 24), Schirmer*s test (weeks 0, 12, 24), Ocular Staining Score (OSS) (weeks 0, 12, 24), unstimulated whole salivary flow (UWS) (weeks 0, 12, 24), Salivary gland ultrasonography (SGUS) (Hocevar score) (weeks 0, 12, 24), rheumatoid factor (RF) and total IgG concentration in blood (weeks 0, 8, 12, 20, 24). 4. ESSDAI (continuous) (weeks 0, 8, 12, 20, 24) 5. The (Clin)ESSDAI minimal clinically important improvement (MCII, defined as decrease of >=3 points) and low disease activity (LDA, defined as score

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)