NCT02364986

Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: PD Dr. Marcus Müller · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

There are two standard and a few second line treatments for RRMS. Since the disease cannot be cured by these existing treatments and all treatment options have significant limitations, there is the need to develop new treatment strategies to improve therapy of patients with RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of the volunteers in the early clinical trials with RIG-I ligand. The RESI study is designed to analyse immune readouts and potential biomarkers such as type I IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8), as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5 and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand will start in healthy volunteers and will be continued in MS patients we need data from both populations since they could show significant differences in response to IFN-b. Thus, the RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment, and RRMS-patients who have to yet started a therapy with Rebif/Avonex.

Detailed description

Study subjects receive either Rebif or Avonex. Rebif is applied s.c. at a dose of 44 µg on day 1, day 3, day 5 and day 8, Avonex i.m. at a dose of 30µg on day 1 and 8. Blood samples are taken before application and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application to analyse the occuring immune response. The total duration of the trial for the individual subject are 9 days. An MRI ist performed before the first application of IMP and at the end of the study to investigate the correlation of Rebif/Avonex application and depression.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Rebif®	Rebif® 44µg (day 1, 3, 5 and 8) s.c.
DRUG	Avonex	Avonex 30µg (day 1 and 8) i.m.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-02-18
• Last updated: 2016-06-03

Locations

2 sites across 1 country: Germany