Lupus Erythematosus, SystemicPhase 1NCT05203419
Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing MHS552 in people with Lupus Erythematosus, Systemic, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- MHS552
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2022to 4 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfills the 2019 EULAR/American College of Rheumatology (ACR) classification criteria for SLE at least 3 months prior to and at screening.
- Patients with mild or moderately active SLE (SLEDAI-2K between 3 and 10, inclusive) at screening. Patients with cutaneous lupus are eligible as long as they satisfy the criteria for systemic lupus.
- Patients must be on stable dose(s) of at least one of the following medications, unless the medication has been discontinued due to intolerance, inadequate response, or patient/physician decision:
- steroid at a dose ≥ 5mg but <30 mg of prednisone (or equivalent) per day,
- antimalarial (hydroxychloroquine/chloroquine/quinacrine) or thalidomide,
- disease modifying anti-rheumatic drugs (DMARDs):
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- methotrexate (MTX),
- azathioprine (AZA),
- mizoribine,
- mycophenolate derivates. Steroid dose must be stable for at least 4 weeks prior to the first dosing. The dose of the other medications above must be stable for at least 12 weeks prior to the first dosing. If the patient is not on any medications listed above, they must have been off these medications for at least 12 weeks prior to dosing.
Who cannot join
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Patients with central nervous system (CNS) lupus, active Lupus Nephritis, any type of lupus flare requiring pulse steroid or immunosuppressive therapy with cyclophosphamide, rituximab, calcineurin inhibitors, or others except those permitted in the inclusion criteria.
- Systemic autoimmune disease other than lupus, which would interfere with participation in the study according to the Investigator's judgement. Treated, stable Hashimoto's thyroiditis is not exclusionary.
- Any of the following abnormal laboratory values at Screening or pre-dose Day 1 assessment:
- Hemoglobin levels below 8.0 g/dL at screening Eosinophil count >700 mm3 or >2 X Upper Limit of Normal (ULN), whichever is lower.
- History of capillary leak syndrome (CLS).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period.
Read the detailed description
This was a Phase 1b, randomized, placebo-controlled, participant- and investigator- blinded, two-part non-confirmatory multiple ascending dose (MAD) study in adult patients aged 18-65 (inclusive) with active SLE disease (mild-moderate).This MAD study was planned to be conducted in two parts, Part A and Part B sequentially, but the study was terminated before Part B was initiated.
In Part A, after a screening period of up to 6 weeks, participants were randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A was planned to consist of up to 3 cohorts (low, medium, high dose). Due to termination of the trial, Part A consisted of 2 cohorts (low and medium doses). Participants were followed-up during 8 weeks post last dose. The total duration of study participation of Part A was approximately 120 Days.
In Part B (not started due to termination of the trial), it was planned that after a screening period of up to 28 days, approximately 12 participants to be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose to be confirmed).
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- MHS552, Placebo
- Keywords
- Systemic Lupus Erythematosus, Lupus, autoimmune disease, inflammatory disease, inflammation
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHS552Drug
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
PlaceboDrug
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 - MHS552 low dose | Experimental | Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part A: Cohort 1, 2, 3 - Placebo | Placebo comparator | Participants will receive placebo once weekly subcutaneously for 4 weeks Receives: Drug: Placebo |
| Part A: Cohort 2 - MHS552 medium dose | Experimental | Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part A: Cohort 3 - MHS552 high dose | Experimental | Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks Receives: Drug: MHS552 |
| Part B: MHS552 | Experimental | Participants will receive MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks Receives: Drug: MHS552 |
| Part B: Placebo | Placebo comparator | Participants will receive placebo once weekly subcutaneously for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Numbers of participants with AEs and SAEs, and other safety data such as vital signs, electrocardiograms (ECG) and laboratory results
Measured: Part A: up to 12 weeks; Part B: up to 20 weeks
Secondary outcomes (3)
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Characterize the AUCtau profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Maximum Observed Blood Concentrations (Cmax) for MHS552
Characterize the Cmax profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Characterize the Tmax profile profile following multiple doses of MHS552
Measured: Part A: up to Day 78; Part B: up to Day 134
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start15 Mar 2022
- Primary completion4 Jun 2023
- Study completion4 Jun 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203419
- Sponsor's protocol ID
- CMHS552D12101
- Other IDs
- 2021-003520-33
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT05203419
- Acronym / sponsor ID
- CMHS552D12101
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus, Lupus, autoimmune disease, inflammatory disease, inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period.
Detailed description
This was a Phase 1b, randomized, placebo-controlled, participant- and investigator- blinded, two-part non-confirmatory multiple ascending dose (MAD) study in adult patients aged 18-65 (inclusive) with active SLE disease (mild-moderate).This MAD study was planned to be conducted in two parts, Part A and Part B sequentially, but the study was terminated before Part B was initiated.
In Part A, after a screening period of up to 6 weeks, participants were randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A was planned to consist of up to 3 cohorts (low, medium, high dose). Due to termination of the trial, Part A consisted of 2 cohorts (low and medium doses). Participants were followed-up during 8 weeks post last dose. The total duration of study participation of Part A was approximately 120 Days.
In Part B (not started due to termination of the trial), it was planned that after a screening period of up to 28 days, approximately 12 participants to be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose to be confirmed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 - MHS552 low dose | Experimental | Drug: MHS552Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks |
| Part A: Cohort 1, 2, 3 - Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once weekly subcutaneously for 4 weeks |
| Part A: Cohort 2 - MHS552 medium dose | Experimental | Drug: MHS552Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks |
| Part A: Cohort 3 - MHS552 high dose | Experimental | Drug: MHS552Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks |
| Part B: MHS552 | Experimental | Drug: MHS552Participants will receive MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once weekly subcutaneously for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fulfills the 2019 EULAR/American College of Rheumatology (ACR) classification criteria for SLE at least 3 months prior to and at screening.
- Patients with mild or moderately active SLE (SLEDAI-2K between 3 and 10, inclusive) at screening. Patients with cutaneous lupus are eligible as long as they satisfy the criteria for systemic lupus.
- Patients must be on stable dose(s) of at least one of the following medications, unless the medication has been discontinued due to intolerance, inadequate response, or patient/physician decision:
Key exclusion criteria (7 listed)
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Patients with central nervous system (CNS) lupus, active Lupus Nephritis, any type of lupus flare requiring pulse steroid or immunosuppressive therapy with cyclophosphamide, rituximab, calcineurin inhibitors, or others except those permitted in the inclusion criteria.
- Systemic autoimmune disease other than lupus, which would interfere with participation in the study according to the Investigator's judgement. Treated, stable Hashimoto's thyroiditis is not exclusionary.
- Any of the following abnormal laboratory values at Screening or pre-dose Day 1 assessment:
- Hemoglobin levels below 8.0 g/dL at screening Eosinophil count >700 mm3 or >2 X Upper Limit of Normal (ULN), whichever is lower.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHS552MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B) | Drug | Part A: Cohort 1 - MHS552 low dose, Part A: Cohort 2 - MHS552 medium dose, Part A: Cohort 3 - MHS552 high dose, Part B: MHS552 |
| PlaceboPlacebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B) | Drug | Part A: Cohort 1, 2, 3 - Placebo, Part B: Placebo |
Primary outcome
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: Part A: up to 12 weeks; Part B: up to 20 weeks
Numbers of participants with AEs and SAEs, and other safety data such as vital signs, electrocardiograms (ECG) and laboratory results
3 secondary outcomes
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Maximum Observed Blood Concentrations (Cmax) for MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Study ResultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MHS552 in people with Lupus Erythematosus, Systemic, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: Part A: up to 12 weeks; Part B: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.