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

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02472795
Collaborator
(none)
105
Enrollment
18
Locations
5
Arms
21
Actual Duration (Months)
5.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Jan 23, 2017
Actual Study Completion Date :
Feb 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cenerimod 0.5 mg (Part A)

Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.

Drug: Cenerimod
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).
Other Names:
  • ACT-334441

    		•
    Experimental: Cenerimod 1 mg (Part A)

    Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.

    Drug: Cenerimod
    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).
    Other Names:
  • ACT-334441

    		•
    Experimental: Cenerimod 2 mg (Part A)

    Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.

    Drug: Cenerimod
    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).
    Other Names:
  • ACT-334441

    		•
    Experimental: Cenerimod 4 mg (Part B)

    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.

    Drug: Cenerimod
    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).
    Other Names:
  • ACT-334441

    		•
    Placebo Comparator: Matching placebo (Part A and B)

    Capsules of matching placebo taken orally once daily for 12 weeks.

    Drug: Matching 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).
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) [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.

    2. Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigator Site Anniston Alabama United States 36207
    2 Investigator Site Clearwater Florida United States 33765
    3 Investigator Site Minsk Belarus 220116
    4 Investigator Site Minsk Belarus 223041
    5 Investigator Site Vitebsk Belarus 210037
    6 Investigator Site Plovdiv Bulgaria 4000
    7 Investigator Site Plovdiv Bulgaria 4002
    8 Investigator Site Sofia Bulgaria 1612
    9 Investigator Site Tbilisi Georgia 0186
    10 Investigator Site Kemerovo Russian Federation 650066
    11 Investigator Site Kursk Russian Federation 305007
    12 Investigator Site Omsk Russian Federation 644111
    13 Investigator Site Orenburg Russian Federation 460018
    14 Investigator Site Smolensk Russian Federation 214025
    15 Investigator Site Vladimir Russian Federation 600023
    16 Investigator Site Vinnytsya Ukraine 21018
    17 Investigator Site Vinnytsya Ukraine 21029
    18 Investigator Site Zaporizhia Ukraine 69600

    Sponsors and Collaborators

    • Idorsia Pharmaceuticals Ltd.

    Investigators

    • Study Director: Study Director, Idorsia Pharmaceuticals Ltd.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Idorsia Pharmaceuticals Ltd.
    ClinicalTrials.gov Identifier:
    NCT02472795
    Other Study ID Numbers:
    • AC-064A201
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Feb 26, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Idorsia Pharmaceuticals Ltd.
    Systemic lupus erythematosus
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic

    Study Results

    Participant Flow

    Recruitment Details This study was conducted at 18 sites in 6 countries between 1 June 2015 and 28 February 2017, 105 patients signed consent and 67 were randomized to a study treatment: 49 in part A (randomized 1:1:1:1 to receive cenerimod 0.5, 1, 2 mg or placebo) and 18 in part B (randomized 3:1 to receive cenerimod 4 mg or placebo).
    Pre-assignment Detail The screening period started when the informed consent was signed (up to 30 days before randomization), and ended with randomization. The period included Visit 1 (screening) and the pre-randomization (pre-dose) assessments at Visit 2 (Day 1). Thirty-two patients did not meet the inclusion/exclusion criteria and 6 patients withdrew from the study.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo (Part A and B)
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Period Title: Overall Study
    STARTED 12 12 13 13 17
    Pharmacodynamic Set 12 10 13 13 16
    Modified Pharmacodynamic Analysis Set 12 10 13 9 16
    COMPLETED 12 11 13 13 14
    NOT COMPLETED 0 1 0 0 3

    Baseline Characteristics

    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo (Part A and Part B) Total
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. Total of all reporting groups
    Overall Participants 12 12 13 13 17 67
    Age (years) [Mean (Standard Deviation) ]
    Full analysis set
    41.4
    (13.2)
    37.0
    (6.4)
    39.2
    (11.8)
    41.7
    (8.1)
    41.0
    (9.5)
    40.1
    (9.9)
    Pharmacodynamic analysis set
    41.4
    (13.2)
    38.1
    (5.4)
    39.2
    (11.8)
    41.7
    (8.1)
    41.8
    (9.2)
    40.6
    (9.8)
    Modified pharmacodynamics analysis set
    41.4
    (13.2)
    38.1
    (5.4)
    39.2
    (11.8)
    41.9
    (8.6)
    41.8
    (9.2)
    40.6
    (9.9)
    Sex: Female, Male (Count of Participants)
    Female
    11
    91.7%
    12
    100%
    12
    92.3%
    10
    76.9%
    16
    94.1%
    61
    91%
    Male
    1
    8.3%
    0
    0%
    1
    7.7%
    3
    23.1%
    1
    5.9%
    6
    9%
    Female
    11
    91.7%
    10
    83.3%
    12
    92.3%
    10
    76.9%
    16
    94.1%
    59
    88.1%
    Male
    1
    8.3%
    0
    0%
    1
    7.7%
    3
    23.1%
    0
    0%
    5
    7.5%
    Female
    11
    91.7%
    10
    83.3%
    12
    92.3%
    7
    53.8%
    16
    94.1%
    56
    83.6%
    Male
    1
    8.3%
    0
    0%
    1
    7.7%
    2
    15.4%
    0
    0%
    4
    6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    12
    100%
    12
    100%
    13
    100%
    13
    100%
    17
    100%
    67
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    11.8%
    2
    3%
    White
    12
    100%
    12
    100%
    13
    100%
    13
    100%
    15
    88.2%
    65
    97%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    11.8%
    2
    3%
    White
    12
    100%
    10
    83.3%
    13
    100%
    13
    100%
    14
    82.4%
    62
    92.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    11.8%
    2
    3%
    White
    12
    100%
    10
    83.3%
    13
    100%
    9
    69.2%
    14
    82.4%
    58
    86.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    1
    8.3%
    1
    8.3%
    0
    0%
    0
    0%
    2
    11.8%
    4
    6%
    Ukraine
    3
    25%
    1
    8.3%
    2
    15.4%
    1
    7.7%
    2
    11.8%
    9
    13.4%
    Georgia
    2
    16.7%
    1
    8.3%
    1
    7.7%
    1
    7.7%
    1
    5.9%
    6
    9%
    Belarus
    0
    0%
    1
    8.3%
    2
    15.4%
    2
    15.4%
    2
    11.8%
    7
    10.4%
    Bulgaria
    3
    25%
    2
    16.7%
    2
    15.4%
    7
    53.8%
    5
    29.4%
    19
    28.4%
    Russia
    3
    25%
    6
    50%
    6
    46.2%
    2
    15.4%
    5
    29.4%
    22
    32.8%
    Body mass index (kg/m^2) [Mean (Standard Deviation) ]
    Full analysis set
    25.2
    (5.1)
    27.4
    (8.0)
    26.0
    (5.1)
    27.5
    (4.7)
    25.4
    (6.8)
    26.3
    (6.0)
    Pharmacodynamic analysis set
    25.2
    (5.1)
    28.8
    (8.1)
    26.0
    (5.1)
    27.5
    (4.7)
    25.5
    (7.0)
    26.5
    (6.1)
    Modified pharmacodynamic analysis set
    25.2
    (5.1)
    28.8
    (8.1)
    26.0
    (5.1)
    28.3
    (5.4)
    25.5
    (7.0)
    26.5
    (6.2)
    Disease history time from first Systemic Lupus Erythematosus symptoms (years) [Median (Full Range) ]
    Full analysis set
    3.7
    8.2
    6.7
    4.6
    7.9
    6.0
    Pharmacodynamic analysis set
    3.7
    9.2
    6.7
    4.6
    7.9
    6.2
    Modified pharmacodynamic analysis set
    3.7
    9.2
    6.7
    3.2
    7.9
    6.2
    Time from first Systemic Lupus Erythematosus diagnosis (years) [Median (Full Range) ]
    Full analysis set
    2.4
    6.2
    4.5
    2.9
    4.9
    3.8
    Pharmacodynamic analysis set
    2.4
    5.8
    4.5
    2.9
    5.0
    3.6
    Modified pharmacodynamic analysis set
    2.4
    5.8
    4.5
    1.3
    5.0
    3.6
    Number of American College of Rheumatology criteria ongoing at screening (Count of Participants)
    0 to 3 ACR criteria ongoing at screening
    5
    41.7%
    3
    25%
    5
    38.5%
    1
    7.7%
    6
    35.3%
    20
    29.9%
    4 to 11 ACR criteria ongoing at screening
    7
    58.3%
    9
    75%
    8
    61.5%
    12
    92.3%
    11
    64.7%
    47
    70.1%
    0 to 3 ACR criteria more than 6 months ago
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4 to 11 ACR criteria more than 6 months ago
    12
    100%
    12
    100%
    13
    100%
    13
    100%
    17
    100%
    67
    100%
    Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia (units on a scale) [Mean (Standard Deviation) ]
    Full analysis set
    7.3
    (3.3)
    8.3
    (3.7)
    7.1
    (2.3)
    8.7
    (3.1)
    7.4
    (3.3)
    7.7
    (3.1)
    Pharmacodynamic analysis set
    7.3
    (3.3)
    7.0
    (2.2)
    7.1
    (2.3)
    8.7
    (3.1)
    7.3
    (3.4)
    7.5
    (2.9)
    Modified pharmacodynamic analysis set
    7.3
    (3.3)
    7.0
    (2.2)
    7.1
    (2.3)
    8.1
    (2.5)
    7.3
    (3.4)
    7.3
    (2.8)

    Outcome Measures

    1. Primary Outcome
    Title Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
    Description 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.
    Time Frame Baseline to end-of-treatment (EOT) (up to 12 weeks)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Measure Participants 12 10 13 13 16
    Mean (Standard Deviation) [10^9 cells/L]
    -0.26
    (0.48)
    -0.96
    (0.68)
    -0.86
    (0.61)
    -0.87
    (1.24)
    -0.33
    (0.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cenerimod 0.5 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.56 to 0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cenerimod 1 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.91 to 0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cenerimod 2 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cenerimod 4 mg (Part B), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.37
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.19
    Estimation Comments
    2. Primary Outcome
    Title Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
    Description 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.
    Time Frame Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Measure Participants 12 12 13 13 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)
    3. Post-Hoc Outcome
    Title Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) Based on Pharmacokinetic Cthrough Profiles
    Description 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 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. The modified pharmacodynamics analysis set includes all participants who: received at least 21 days of study treatment & with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) & with cenerimod plasma concentrations at Week 4 consistent with expectations.
    Time Frame Baseline to end-of-treatment (EOT) (up to 12 weeks)

    Outcome Measure Data

    Analysis Population Description
    Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic analysis set to form a modified pharmacodynamics analysis set.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Measure Participants 12 10 13 9 16
    Mean (Standard Deviation) [10^9 cells/L]
    -0.26
    (0.48)
    -0.96
    (0.68)
    -0.86
    (0.61)
    -1.48
    (0.73)
    -0.32
    (0.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cenerimod 0.5 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2837
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.145
    Confidence Interval (2-Sided) 95%
    -0.413 to 0.123
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.134
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cenerimod 1 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.515
    Confidence Interval (2-Sided) 95%
    -0.797 to -0.234
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.140
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cenerimod 2 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.565
    Confidence Interval (2-Sided) 95%
    -0.825 to -0.305
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.130
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cenerimod 4 mg (Part B), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.880
    Confidence Interval (2-Sided) 95%
    -1.173 to -0.586
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.147
    Estimation Comments
    4. Post-Hoc Outcome
    Title Absolute Values of Total Lymphocyte Count at Each Analysis Visit
    Description The primary objective of the clinical study was to see whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The modified pharmacodynamics analysis set includes all participants who: received at least 21 days of study treatment & with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) & with cenerimod plasma concentrations at Week 4 consistent with expectations.
    Time Frame Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment (EOT - up to 12 weeks), end-of-study (6 weeks after EOT)

    Outcome Measure Data

    Analysis Population Description
    All participants for which data was available. Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomised to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the PD set to form a modified pharmacodynamic analysis set.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Measure Participants 12 10 13 9 16
    Baseline visit
    1.37
    (0.52)
    1.83
    (0.79)
    1.62
    (0.75)
    2.04
    (0.80)
    1.66
    (0.91)
    Week 2 visit
    1.24
    (0.34)
    1.38
    (0.49)
    1.19
    (0.89)
    0.79
    (0.44)
    1.44
    (0.44)
    Week 4 visit
    1.09
    (0.27)
    0.99
    (0.38)
    0.73
    (0.39)
    0.71
    (0.49)
    1.31
    (0.5)
    Week 8 visit
    1.08
    (0.43)
    0.91
    (0.40)
    0.73
    (0.36)
    0.51
    (0.28)
    1.49
    (0.73)
    Week 12 visit
    1.11
    (0.37)
    0.87
    (0.34)
    0.76
    (0.44)
    0.57
    (0.21)
    1.33
    (0.54)
    End-of-treatment visit
    1.11
    (0.37)
    0.87
    (0.34)
    0.76
    (0.44)
    0.57
    (0.21)
    1.34
    (0.51)
    End-of-study visit
    1.42
    (0.37)
    1.42
    (0.58)
    1.35
    (0.45)
    1.14
    (0.52)
    1.71
    (0.86)
    5. Post-Hoc Outcome
    Title Total Lymphocyte Count Percent Change From Baseline to End-of-treatment (EOT)
    Description Percentage change in total lymphocyte count from baseline to end-of-treatment (EOT). Percent change from baseline is defined as the absolute change from baseline divided by the baseline value (if the baseline value is > 0) and then multiplied by 100. 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 modified pharmacodynamics analysis set includes all participants who: received at least 21 days of study treatment & with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) & with cenerimod plasma concentrations at Week 4 consistent with expectations.
    Time Frame Baseline to End of Treatment (EOT) (up to 12 weeks)

    Outcome Measure Data

    Analysis Population Description
    Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic set to form a modified pharmacodynamic analysis set.
    Arm/Group Title Cenerimod 0.5 mg (Part A) Cenerimod 1 mg (Part A) Cenerimod 2 mg (Part A) Cenerimod 4 mg (Part B) Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    Measure Participants 12 10 13 9 16
    Mean (Standard Deviation) [Percent change of total lymphocyte count]
    -12.23
    (34.29)
    -47.76
    (20.37)
    -51.52
    (22.53)
    -69.27
    (13.68)
    -5.04
    (39.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cenerimod 0.5 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1755
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.214
    Confidence Interval (2-Sided) 95%
    -32.513 to 6.085
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.626
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cenerimod 1 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -39.311
    Confidence Interval (2-Sided) 95%
    -59.552 to -19.069
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 10.096
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cenerimod 2 mg (Part A), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -47.278
    Confidence Interval (2-Sided) 95%
    -65.981 to -28.574
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.329
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cenerimod 4 mg (Part B), Matching Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -56.452
    Confidence Interval (2-Sided) 95%
    -77.585 to -35.320
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 10.541
    Estimation Comments

    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.
    Adverse Event Reporting Description
    Arm/Group Title Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Matching Placebo
    Arm/Group Description Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. Participants received cenerimod matching placebo capsules orally once daily for 12 weeks.
    All Cause Mortality
    Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Matching Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/13 (0%) 0/17 (0%)
    Serious Adverse Events
    Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Matching Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/13 (0%) 1/17 (5.9%)
    Gastrointestinal disorders
    Pancreatitis chronic 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 2
    Hepatobiliary disorders
    Cholecystitis chronic 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Post cholecystectomy syndrome 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Other (Not Including Serious) Adverse Events
    Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg Matching Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/12 (41.7%) 5/12 (41.7%) 6/13 (46.2%) 5/13 (38.5%) 9/17 (52.9%)
    Blood and lymphatic system disorders
    Anaemia 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Lymphopenia 0/12 (0%) 0 1/12 (8.3%) 1 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Neutropenia 2/12 (16.7%) 2 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 2
    Eye disorders
    Age-related macular degeneration 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Cataract 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Dry age-related macular degeneration 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Visual acuity reduced 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Abdominal discomfort 1/12 (8.3%) 1 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Abdominal pain lower 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Diarrhoea 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 2
    Dyspepsia 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Gastroduodenitis 0/12 (0%) 0 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Nausea 1/12 (8.3%) 1 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Hepatobiliary disorders
    Chronic hepatitis 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Infections and infestations
    Asymptomatic bacteriuria 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Erysipelas 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Nasopharyngitis 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 2/17 (11.8%) 2
    Periodontitis 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Respiratory tract infection 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Respiratory tract infection viral 0/12 (0%) 0 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Rhinitis 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Tracheobronchitis 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Investigations
    Alanine aminotransferase increased 2/12 (16.7%) 2 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Aspartate aminotransferase increased 1/12 (8.3%) 1 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Bilirubin conjugated increased 1/12 (8.3%) 1 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Blood alkaline phosphatase increased 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Blood bilirubin increased 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Blood fibrinogen decreased 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Blood potassium decreased 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 1 0/13 (0%) 0 0/17 (0%) 0
    Electrocardiogram T wave amplitude decreased 0/12 (0%) 0 0/12 (0%) 0 1/13 (7.7%) 2 0/13 (0%) 0 0/17 (0%) 0
    Intraocular pressure increased 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Laboratory test abnormal 1/12 (8.3%) 1 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Lymphocyte count decreased 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Neutrophil count decreased 1/12 (8.3%) 1 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 2
    Metabolism and nutrition disorders
    Hypokalaemia 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Type 2 diabetes mellitus 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/12 (0%) 0 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Joint swelling 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders
    Headache 2/12 (16.7%) 2 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Renal and urinary disorders
    Nitrituria 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Proteinuria 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0
    Epistaxis 1/12 (8.3%) 2 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Pneumonitis 0/12 (0%) 0 1/12 (8.3%) 1 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 1/17 (5.9%) 1
    Nail dystrophy 1/12 (8.3%) 1 0/12 (0%) 0 0/13 (0%) 0 0/13 (0%) 0 0/17 (0%) 0
    Surgical and medical procedures
    Tooth extraction 0/12 (0%) 0 0/12 (0%) 0 0/13 (0%) 0 1/13 (7.7%) 1 0/17 (0%) 0

    Limitations/Caveats

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

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Clinical Trial Disclosure Desk
    Organization Idorsia Pharmaceuticals Ltd
    Phone +41 58 844 1977
    Email clinical-trials-disclosure@idorsia.com
    Responsible Party:
    Idorsia Pharmaceuticals Ltd.
    ClinicalTrials.gov Identifier:
    NCT02472795
    Other Study ID Numbers:
    • AC-064A201
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Feb 26, 2020
    Last Verified:
    Feb 1, 2020