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Clinical trials
NCT07621809

Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

ClinicalTrials.gov identifier NCT07621809

Novartis reference CVAY736A22301

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Condition Sjögren´s Disease

Study status Recruiting

Phase 3

Number of participants 570

Gender All

Age 18 years or above

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Study details

This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden.

Interventions

DRUG: VAY736|DRUG: Placebo

Official title

A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

Inclusion Criteria

Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
Seropositive for anti-Ro/SSA antibodies at screening
SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
Stimulated whole salivary flow (sSF) rate \> 0.3 mL/min at screening
Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.

Exclusion Criteria

Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
Systemic sclerosis (SSc)
Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
36 weeks prior to randomization, or
As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
Prior treatment with ianalumab
Prior treatment with any of the following within the given period prior to Screening:
Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20).

Home
Clinical trials
NCT07621809

Study of an Investigational Treatment for Sjögren's Disease With High Symptoms

ClinicalTrials.gov identifier NCT07621809

Novartis reference CVAY736A22301

Show study information as

Condition Sjögren´s Disease

Study status Recruiting

Phase 3

Number of participants 570

Gender All

Age 18 years or above

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment compared with a placebo (a placebo looks like the investigational treatment but does not contain active medication) in adults with Sjögren's disease who have a high symptom burden.

Participants will receive either the investigational treatment or a placebo for 52 weeks. The study treatment is given as an injection under the skin once a month. Participants who already take hydroxychloroquine may be able to keep taking it if their dose has been stable. Participants may also be allowed to take a low daily dose of predniso(lo)ne for a limited time after starting the study.

This study may be an option for
Adults with Sjögren's disease may be able to participate if they:

Are age 18 or older (or the legal adult age in their country, if higher)
Meet the 2016 ACR/EULAR criteria for Sjögren's disease
Have a positive anti-Ro/SSA antibody test at screening
Have high Sjögren's symptoms based on daily symptom scores collected over 14 days during screening
Have Sjögren's-related activity in certain organ or blood-related areas based on a screening score
Have a stimulated saliva flow rate above a minimum level at screening

Study timeline and visits:
Treatment lasts 52 weeks, with study injections given monthly.

Interventions

DRUG: VAY736|DRUG: Placebo

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Are male or female and are age 18 or older (or the legal adult age in their country, if higher)
Meet the 2016 ACR/EULAR criteria for Sjögren's disease
Have a positive anti-Ro/SSA antibody test at screening
Have high mouth dryness symptoms and a high overall Sjögren's symptom score based on scores collected over 14 days during the second screening period
Have a screening Sjögren's disease activity score showing at least some activity in the biologic and/or blood-related (hematologic) areas; any lab results used for this score must be confirmed to be caused by Sjögren's disease and not another condition
Have a stimulated whole saliva flow rate above 0.3 mL per minute at screening
If taking hydroxychloroquine (400 mg per day or less), have been on a stable dose for at least 4 weeks before screening and stay on the same dose during the 52-week blinded treatment period
If taking predniso(lo)ne (5 mg per day or less, or an equivalent steroid dose), use is allowed for up to 16 weeks after assignment to study treatment

You might not be able to join if

Have another autoimmune rheumatic disease that is active and is the main illness, including systemic sclerosis
Have another connective tissue disease (for example, lupus nephritis, large vessel vasculitis, or mixed connective tissue disease) that is active and needs immune-suppressing treatment outside what this study allows, and would interfere with assessing Sjögren's disease organ involvement
Have a current diagnosis or past history of fibromyalgia, or have overlapping inflammatory diseases
Have had B-cell-depleting treatment (for example, rituximab or similar treatments) within 36 weeks before assignment to study treatment
Have had B-cell-depleting treatment and still have a B-cell count below the lower limit of normal, or below the level you had before that prior B-cell-depleting treatment (whichever is lower) at screening
Have previously been treated with the investigational treatment used in this study
Have previously been treated with certain biologic or similar treatments too close to screening, including within 5 drug half-lives before screening for: iscalimab, belimumab, abatacept, anti-TNFα biologic agents, immunoglobulins given by vein or under the skin, plasmapheresis, or any other investigational biologic treatments being studied for Sjögren's disease
Have previously been treated with certain immune-suppressing medicines too close to screening, including within 4 weeks before screening, or within the drug’s 5 half-lives elimination time if that is longer than 4 weeks, for: cyclophosphamide (by vein or by mouth), mycophenolate mofetil, methotrexate, azathioprine, cyclosporine A (by vein or by mouth), JAK inhibitors, other kinase inhibitors, or other immunosuppressants
Have had an allergic reaction (hypersensitivity) to any study treatment or its ingredients, or to similar types of medicines (for example, IgG1 monoclonal antibodies), or to ingredients in the study drug formulation such as sucrose, L-histidine hydrochloride/L-histidine, or polysorbate 20

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