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Trial record 22 of 698 for:    lupus

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02472795
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
International trial to evaluate the biological activity and safety of ACT-334441 in lupus patients.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Placebo Drug: ACT-334441 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 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 : June 1, 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Investigational treatment - 0.5mg
ACT-334441 0.5 mg
Drug: ACT-334441
Selective Sphingosine 1-phosphate (S1P) modulator
Other Name: Cenerimod

Experimental: Investigational treatment - 1mg
ACT-334441 1 mg
Drug: ACT-334441
Selective Sphingosine 1-phosphate (S1P) modulator
Other Name: Cenerimod

Experimental: Investigational treatment - 2mg
ACT-334441 2 mg
Drug: ACT-334441
Selective Sphingosine 1-phosphate (S1P) modulator
Other Name: Cenerimod

Experimental: Investigational treatment - 4mg
ACT-334441 4 mg
Drug: ACT-334441
Selective Sphingosine 1-phosphate (S1P) modulator
Other Name: Cenerimod

Placebo Comparator: placebo
administered orally
Drug: Placebo
Placebo matching ACT-334441 capsules or Experimental doses




Primary Outcome Measures :
  1. Change in total lymphocyte count from baseline to End of Treatment (EOT) [ Time Frame: Baseline to End of Treatment (EOT) (12 weeks) ]
    Total lymphocyte count at EOT minus total lymphocyte count at baseline

  2. Treatment-emergent adverse events (including serious adverse events) [ Time Frame: Baseline to End of Study (EOS) (18 weeks) / Follow-up ]
    Treatment-emergent AEs (and SAEs) from first study treatment intake up to 6 weeks (inclusive) after last study treatment intake


Other Outcome Measures:
  1. ACT-334441 plasma concentration [ Time Frame: Baseline to End of Treatment (EOT) (12 weeks) and End of Study (EOS) (18 weeks) ]
    Ctrough ACT-334441 plasma concentrations prior to dosing at each study visits until EOS

  2. Change in disease activity (SLEDAI-2K) [ Time Frame: Baseline to End of Treatment (EOT) (12 weeks) and End of Study (EOS) (18 weeks) ]
    Change in SLEDAI-2K score from baseline to each post-baseline assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18 to 65 years with established SLE. Subjects 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 subjects must be treated with background SLE medications.

Exclusion Criteria:

  • Subjects 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.
  • Subjects 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472795


Locations
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United States, Alabama
Investigator Site
Anniston, Alabama, United States, 36207
United States, Florida
Investigator Site
Clearwater, Florida, United States, 33765
Belarus
Investigator Site
Minsk, Belarus, 220116
Investigator Site
Minsk, Belarus, 223041
Investigator Site
Vitebsk, Belarus, 210037
Bulgaria
Investigator Site
Plovdiv, Bulgaria, 4000
Investigator Site
Plovdiv, Bulgaria, 4002
Investigator Site
Sofia, Bulgaria, 1612
Georgia
Investigator Site
Tbilisi, Georgia, 0186
Russian Federation
Investigator Site
Kemerovo, Russian Federation, 650066
Investigator Site
Kursk, Russian Federation, 305007
Investigator Site
Omsk, Russian Federation, 644111
Investigator Site
Orenburg, Russian Federation, 460018
Investigator Site
Smolensk, Russian Federation, 214025
Investigator Site
Vladimir, Russian Federation, 600023
Ukraine
Investigator Site
Vinnytsya, Ukraine, 21018
Investigator Site
Vinnytsya, Ukraine, 21029
Investigator Site
Zaporizhia, Ukraine, 69600
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02472795     History of Changes
Other Study ID Numbers: AC-064A201
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Keywords provided by Idorsia Pharmaceuticals Ltd.:
Systemic lupus erythematosus

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases