A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)

NCT ID: NCT04988087

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-03-07

Brief Summary

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

Detailed Description

This was 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 first underwent 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 was up to 34 weeks. Participants with SjS were randomized in a 1:1 ratio to MHV370 or placebo and participants with MCTD were randomized in a 1:1 ratio to MHV370 or placebo.

Conditions

Sjogren Syndrome; Mixed Connective Tissue Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SjS participants: MHV370

SjS participants randomized in the MHV370 arm will be treated with MHV370 for 24 weeks. Double-blind supply will be used.

Group Type: EXPERIMENTAL

MHV370

Intervention Type: DRUG

MHV370 for 24 weeks

SjS participants: Placebo

SjS participants randomized in the placebo arm will be treated with placebo for 24 weeks. Double-blind supply will be used.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for 24 weeks

MCTD participants: MHV370

MCTD participants randomized in the MHV370 arm will be treated with MHV370 for 24 weeks. Double-blind supply will be used.

Group Type: EXPERIMENTAL

MHV370

Intervention Type: DRUG

MHV370 for 24 weeks

MCTD participants: Placebo

MCTD participants randomized in the placebo arm will be treated with placebo for 24 weeks. Double-blind supply will be used.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for 24 weeks

Interventions

MHV370

MHV370 for 24 weeks

Intervention Type: DRUG

Placebo

Placebo for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

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
• Screening ESSDAI (based on weighted score) ≥ 5 from 8 defined domains (biologic, hematologic, articular, cutaneous, glandular, lymphadenopathy, renal, constitutional).

MCTD:

• 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:

• 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
• 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)
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they use a highly effective method of contraception

SjS:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Székesfehérvár, Fejér, Hungary

Novartis Investigative Site

Debrecen, , Hungary

Novartis Investigative Site

Bialystok, Podlaskie Voivodeship, Poland

Novartis Investigative Site

Lublin, , Poland

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Kaohsiung City, , Taiwan

Countries

China; Germany; Hungary; Poland; Spain; Taiwan

References

Raaphorst J, Gullick NJ, Shokraneh F, Brassington R, Min M, Ali SS, Gordon PA. Non-targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies. Cochrane Database Syst Rev. 2025 Aug 11;8(8):CD015855. doi: 10.1002/14651858.CD015855.

Reference Type: DERIVED

PMID: 40787733 (View on PubMed)

Raaphorst J, Gullick NJ, Shokraneh F, Brassington R, Min M, Ali SS, Gordon PA. Targeted immunosuppressive and immunomodulatory therapies for idiopathic inflammatory myopathies. Cochrane Database Syst Rev. 2025 Aug 1;8(8):CD015854. doi: 10.1002/14651858.CD015854.

Reference Type: DERIVED

PMID: 40747756 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1877

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

2020-004937-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMHV370A12201

Identifier Type: -

Identifier Source: org_study_id