A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled, Parallel Group Basket Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjögren's Syndrome or Mixed Connective Tissue Disease

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    60
  • sponsor
    Novartis Pharmaceuticals
Updated on 20 September 2022

Summary

This study is a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).

Description

This is a randomized, participant and investigator blinded, placebo-controlled, multi center parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren's Syndrome (SjS) or with Mixed Connective Tissue Disease (MCTD). Participants will first undergo a screening period of up to 6 weeks, followed by a treatment duration of 24 weeks and a follow-up period of 4 weeks. Total study duration for each participant will be up to 34 weeks. Approximately 60 participants will be enrolled: 48 participants with SjS will be randomized in a 1:1 ratio to MHV370 or placebo and 12 participants with MCTD will be randomized in a 1:1 ratio to MHV370 or placebo.

Details
Condition Sjogren Syndrome, Mixed Connective Tissue Disease
Treatment Placebo, MHV370
Clinical Study IdentifierNCT04988087
SponsorNovartis Pharmaceuticals
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

SjS and MCTD
• Fully vaccinated with any locally approved COVID-19 vaccination including booster
vaccinations if required by local guidelines
SjS
Unstimulated whole salivary flow rate of > 0 mL/min at screening
Classification of Sjögren's Syndrome according to the 2016 ACR/EULAR criteria at
screening
MCTD
Screening ESSDAI (based on weighted score) ≥ 5 from 8 defined domains (biologic
hematologic, articular, cutaneous, glandular, lymphadenopathy, renal, constitutional)
Diagnosis of MCTD based on criteria like a) Raynaud's phenomenon b) At least two of
the four following signs: i) synovitis, ii) myositis, iii) swollen fingers and vi)
interstitial lung disease
Patients with overlap syndromes, i.e. patients meeting diagnostic criteria for
systemic autoimmune disease other than MCTD may be included unless they have major
organ involvement as judged by the investigator

Exclusion Criteria

SjS and MCTD
Pregnant or nursing (lactating) women
SjS
Prior use of B-cell depleting therapy within 6 months of baseline. For participants
who received B-cell depleting therapy within 6 -12 months of baseline visit, B-cell
count should be within normal range
Other protocol-defined inclusion/exclusion criteria may apply
Prior treatment with any of the following within 3 months of baseline: CTLA4-Fc Ig
(abatacept), Anti-TNF mAb, Intravenous Ig, Plasmapheresis, i.v. or oral
cyclophosphamide, i.v. or oral cyclosporine A
Screening CBC laboratory values as follows: Hemoglobin levels < 8 g/dL (< 5 mmol/L)
Total leukocyte count < 2,000/µL (2 x 109/L), Platelets < 50,000/µL (50 x 109/L)
Neutrophil count < 1,000/µL (1 x 109/L)
Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they use a highly effective method of contraception
Sjögren's Syndrome overlap syndromes where another autoimmune disease constitutes the
primary illness
Required regular use of medications known to cause, as a major side effect, dry mouth
eyes
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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