Trial record 3 of 45 for:    regeneron | Open Studies

Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01963598
First received: October 11, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.


Condition Intervention Phase
Sarcopenia
Drug: REGN1033 (SAR391786)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in total lean body mass [ Time Frame: day 1 to day 85 ] [ Designated as safety issue: No ]
    The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85).


Secondary Outcome Measures:
  • TEAEs [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: Yes ]
    TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141).

  • Change in appendicular lean mass [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Changes from baseline (day 1) in appendicular lean mass by DEXA

  • Change in maximal leg press strength (1-RM) [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in maximal leg press strength (1-repetition max)

  • Change in maximal chest press strength (1-RM) [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in maximal chest press strength (1-repetition max)

  • Change in 4M gait speed [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in 4-meter (4M) gait speed

  • Change in SPPB subscores [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in SPPB (Short Physical Performance Battery) subscores

  • Change in distance walked in the 6MWT [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in distance walked in the 6MWT (6-Minute Walk Test)

  • Change in regional and total fat mass by DEXA [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in regional and total fat mass by DEXA

  • Change in hand grip strength by handheld dynamometer [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in hand grip strength by handheld dynamometer

  • Change in unloaded and loaded stair climb power [ Time Frame: day 1 to day 141 ] [ Designated as safety issue: No ]
    Change from baseline in unloaded and loaded stair climb power


Estimated Enrollment: 240
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Dosing regimen 1
Drug: REGN1033 (SAR391786)
Experimental: Group 2
Dosing regimen 2
Drug: REGN1033 (SAR391786) Drug: placebo
Experimental: Group 3
Dosing regimen 3
Drug: REGN1033 (SAR391786) Drug: placebo
Experimental: Group 4
Dosing regimen 4
Drug: placebo

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal)
  2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions
  3. Ability to follow a walking program
  4. Willing and able to comply with clinic visits and study-related procedures
  5. Provide signed informed consent
  6. Able to understand and complete study-related questionnaires

Exclusion Criteria:

  1. Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
  2. Surgical procedure requiring general anesthesia within 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
  3. Participate in resistance training more than 3 times per week and regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
  4. Chronic medications introduced within 2 weeks prior to screening
  5. Respiratory disease that requires oxygen treatment
  6. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
  7. Neurological conditions that are causing impaired muscle function or mobility
  8. Certain cardiovascular conditions
  9. Uncontrolled diabetes

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963598

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

  Show 44 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01963598     History of Changes
Other Study ID Numbers: R1033-SRC-1239
Study First Received: October 11, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014