Systemic Lupus ErythematosusPhase 1/2NCT02472795

Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

A Phase 1/2 study testing Cenerimod in people with Systemic Lupus Erythematosus, run by Viatris Innovation GmbH at 18 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Cenerimod
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 18 sitesin 6 countries
Study dates: 1 Jun 2015to 28 Feb 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
Enrolled participants must be treated with background SLE medications.

Who cannot join

Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.
Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.

Trial locations and contacts

18 sites in 6 countries.

Country

City, postcode or hospital

18 sites in 6 countries

Russia6 sites

Investigator Site
Kemerovo, 650066
Investigator Site
Kursk, 305007
Investigator Site
Omsk, 644111
Investigator Site
Orenburg, 460018
Investigator Site
Smolensk, 214025
Investigator Site
Vladimir, 600023

Other trials in Russia

Belarus3 sites

Investigator Site
Minsk, 220116
Investigator Site
Minsk, 223041
Investigator Site
Vitebsk, 210037

Other trials in Belarus

Bulgaria3 sites

Investigator Site
Plovdiv, 4000
Investigator Site
Plovdiv, 4002
Investigator Site
Sofia, 1612

Other trials in Bulgaria

Ukraine3 sites

Investigator Site
Vinnytsia, 21018
Investigator Site
Vinnytsia, 21029
Investigator Site
Zaporizhia, 69600

Other trials in Ukraine

United States2 sites

Investigator Site
Anniston, Alabama, 36207
Investigator Site
Clearwater, Florida, 33765

Other trials in United States

Georgia1 site

Investigator Site
Tbilisi, 0186

Other trials in Georgia

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Read the detailed description

This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).

In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.

In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.

All participants will receive study medication for 12 weeks.

Conditions: Systemic Lupus Erythematosus
Being tested: Matching placebo, Cenerimod
Keywords: Systemic lupus erythematosus
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Matching placeboDrug
Also called Placebo
One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
CenerimodDrug
Also called ACT-334441
One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).

Study groups in NCT02472795
Study group	Role	What they receive
Cenerimod 0.5 mg (Part A)	Experimental	Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks. Receives: Drug: Cenerimod
Cenerimod 1 mg (Part A)	Experimental	Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks. Receives: Drug: Cenerimod
Cenerimod 2 mg (Part A)	Experimental	Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks. Receives: Drug: Cenerimod
Cenerimod 4 mg (Part B)	Experimental	Participants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment. Receives: Drug: Cenerimod
Matching placebo (Part A and B)	Placebo comparator	Capsules of matching placebo taken orally once daily for 12 weeks. Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).
The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.
A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.
The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.
The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.
End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Measured: Baseline to end-of-treatment (EOT) (up to 12 weeks)
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).
The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline.
A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.
The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.
The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.
End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201528 Feb 2017

First posted16 Jun 2015 (estimated)
Study start1 Jun 2015
Primary completion23 Jan 2017
Study completion28 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02472795
Sponsor's protocol ID: AC-064A201
Status last verified: Feb 2020
First submitted: 14 May 2015
Last updated: 29 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019.
PubMed 31798918

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT02472795
Acronym / sponsor ID: AC-064A201
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Viatris Innovation GmbHIndustry (pharma, biotech, devices)
Study start: 1 Jun 2015 (actual)
Primary completion: 23 Jan 2017 (actual)
Study completion: 28 Feb 2017 (actual)
First posted: 16 Jun 2015 (estimated)
Results: Posted 26 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Detailed description

This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).

In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.

All participants will receive study medication for 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Cenerimod 0.5 mg (Part A)	Experimental	Drug: CenerimodParticipants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.
Cenerimod 1 mg (Part A)	Experimental	Drug: CenerimodParticipants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.
Cenerimod 2 mg (Part A)	Experimental	Drug: CenerimodParticipants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.
Cenerimod 4 mg (Part B)	Experimental	Drug: CenerimodParticipants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment.
Matching placebo (Part A and B)	Placebo comparator	Drug: Matching placeboCapsules of matching placebo taken orally once daily 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 (2 listed)

Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
Enrolled participants must be treated with background SLE medications.

Key exclusion criteria (2 listed)

Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.
Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.

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
Matching placeboAlso: PlaceboOne capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).	Drug	Matching placebo (Part A and B)
CenerimodAlso: ACT-334441One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).	Drug	Cenerimod 0.5 mg (Part A), Cenerimod 1 mg (Part A), Cenerimod 2 mg (Part A), Cenerimod 4 mg (Part B)

Primary outcome

Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
Time frame: Baseline to end-of-treatment (EOT) (up to 12 weeks)
The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.
Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)
The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.

Results and safety

Results posted to the registry on 26 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cenerimod 0.5 mg (Part A)	12	12
Cenerimod 1 mg (Part A)	12	11
Cenerimod 2 mg (Part A)	13	13
Cenerimod 4 mg (Part B)	13	13
Matching Placebo (Part A and B)	17	14

Primary outcome: Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)

Time frame: Baseline to end-of-treatment (EOT) (up to 12 weeks). Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	Cenerimod 0.5 mg (Part A) n = 12	Cenerimod 1 mg (Part A) n = 10	Cenerimod 2 mg (Part A) n = 13	Cenerimod 4 mg (Part B) n = 13	Matching Placebo n = 16
Value	-0.26 (0.48)	-0.96 (0.68)	-0.86 (0.61)	-0.87 (1.24)	-0.33 (0.72)

Cenerimod 0.5 mg (Part A) vs Matching Placebo: Mean Difference (Final Values): -0.17 (95% CI -0.56 to 0.22), p = 0.39, ANCOVA
Cenerimod 1 mg (Part A) vs Matching Placebo: Mean Difference (Final Values): -0.5 (95% CI -0.91 to 0.09), p = 0.02, ANCOVA
Cenerimod 2 mg (Part A) vs Matching Placebo: Mean Difference (Final Values): -0.57 (95% CI -0.95 to -0.19), p = 0.004, ANCOVA

Population analysed: Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.

Primary outcome: Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment

Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks). Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	Cenerimod 0.5 mg (Part A) n = 12	Cenerimod 1 mg (Part A) n = 12	Cenerimod 2 mg (Part A) n = 13	Cenerimod 4 mg (Part B) n = 13	Matching Placebo n = 17
Baseline visit	1.37 (0.52)	1.71 (0.82)	1.62 (0.75)	1.88 (0.77)	1.65 (0.88)
Week 2 visit	-0.13 (0.56)	-0.48 (0.56)	-0.52 (1.03)	-1.09 (0.65)	-0.16 (0.75)
Week 4 visit	-0.28 (0.42)	-0.69 (0.76)	-0.86 (0.63)	-0.68 (1.32)	-0.33 (0.69)
Week 8 Visit	-0.28 (0.60)	-0.92 (0.60)	-0.89 (0.68)	-1.03 (1.12)	-0.09 (0.82)
Week 12 visit	-0.26 (0.48)	-0.72 (1.03)	-0.86 (0.61)	-0.87 (1.24)	-0.29 (0.73)
End-of-treatment visit	-0.26 (0.48)	-0.72 (1.03)	-0.86 (0.61)	-0.87 (1.24)	-0.30 (0.71)

Adverse events

Time frame: All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cenerimod 0.5 mg	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Cenerimod 1 mg	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Cenerimod 2 mg	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Cenerimod 4 mg	0 of 13 (0%)	5 of 13 (38.5%)	0 of 13
Matching Placebo	1 of 17 (5.9%)	9 of 17 (52.9%)	0 of 17

Limitations and caveats (from the sponsor): This study is the first to investigate short-term cenerimod treatment in patients with mild to moderate systemic lupus erythematosus (SLE).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31798918Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019.
Lay summary on results reference by Hermann V et al. First use of cenerimod, a selective S1P(1) receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354.Link 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.

Clinical Trials study director

Viatris Innovation GmbH

18 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cenerimod in people with Systemic Lupus Erythematosus, run by Viatris Innovation GmbH at 18 sites in 6 countries.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Russia, Belarus, Bulgaria, Ukraine, United States and 1 more country. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) (time frame: Baseline to end-of-treatment (EOT) (up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472795, which also lists 1 linked publication.

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 29 Jul 2026.