Skip to content
Find Clinical Trials
Home » Find Clinical Trials » Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Share Print
Servier Protocol Code: CL2-95011-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04605978 EudraCT Number: 2020-001526-59

Find a recruiting site

How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 19 locations

Study description

This study was done to test if S95011 (study drug) is a safe and effective treatment for patients with Primary Sjögren’s Syndrome (PSS).

PSS is a condition in which the body’s immune system attacks all the organs of the body, especially the glands that make fluids like tears, saliva, or sweat. This causes dryness in the eyes, mouth, and other areas of the body. PSS is often associated with fatigue and pain. PSS is much more common in women than in men.

Interleukin-7 (IL-7) is a specific protein that promotes disease by triggering the cells of the immune system. In PSS, IL-7 is found in higher-than-normal amounts.

S95011 is a drug that blocks the action of the IL-7 protein. This drug is yet to be approved by regulatory agencies for the treatment of patients with PSS.

The main goal of this study was to test if S95011 can improve symptoms of patients with PSS, as compared to a placebo. A placebo looks like S95011 but does not have any medicine in it.

Official title: A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study
Results
English (USA)
Conditions
Primary Sjögren's Syndrome
Interventions / Treatments
  • S95011 concentrate for solution for infusion
  • Placebo concentrate for solution for infusion
Other study id numbers
  • CL2-95011-001

Eligibility Criteria

Eligible age for the study

18 years to 75 years (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be 18 to 75 years old.
  • Have been diagnosed with PSS according to specific criteria.

Participants could not take part in the study if:

  • They had any signs of infection within 2 weeks before starting the study.
  • They had a serious disease of any type that could affect the results of the study.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: S95011

S95011 was given through infusion into a vein at the dose of 750 milligrams (mg). An infusion is an injection given slowly. S95011 was given for at least 60 minutes.

Intervention / Treatment
Drug: S95011

Infusions every 2 weeks until week 4 and then every 3 weeks until week 10.

Participant Group / Arm
Placebo Comparator: Placebo

Placebo concentrate for solution for infusion

A placebo looks like S95011 but does not have any medicine in it. Placebo was given through infusion.

Intervention / Treatment
Drug: Placebo

Infusions every 2 weeks until week 4 and then every 3 weeks until week 10.

Keywords

Provided by Servier
Sjögren Sjögren's Syndrome Autoimmune disease Systemic Xerostomia xerophthalmia Salivary gland disease Arthritis Joint disease Monoclonal antibody
Additional Relevant MeSH Terms Glioma
Sjogren's Syndrome Autoimmune Diseases Xerostomia Xerophthalmia Salivary Gland Diseases Arthritis Joint Diseases