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Trial record 5 of 17 for:    affiris

Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA (AFF009)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Affiris AG
Sponsor:
Collaborators:
Chu Hopitaux de Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Forschungszentrum Juelich
University Hospital, Toulouse
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT02270489
First received: September 4, 2014
Last updated: November 19, 2014
Last verified: September 2014
  Purpose

This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA).

In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.

AFF009 is part of the project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).


Condition Intervention Phase
Multiple System Atrophy
Neurodegenerative Diseases
Biological: AFFITOPE® PD01A + Adjuvant
Biological: AFFITOPE® PD03A + Adjuvant
Biological: Adjuvant without active component
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Number of patients who withdraw due to Adverse Events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence of Adverse Events and Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluation of Adverse Events and Serious Adverse Events in regards to autoimmune reactions

  • Physical Examination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    New findings or change in pre-existing findings assessed in physical examinations over time (study period)

  • Vital signs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Change in vital signs. The Evaluation includes the changes in blood pressure, heart rate, respiratory rate and Body temperature over time (measured at each visit).

  • Safety related evaluation of MRI results of patients' brain after visit 5 and visit 8 compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety measures will e.g. include the occurrence of inflammatory reactions (meningoencephalitis), new/changed hemorrhages and lacunar infarcts.

  • Clinical significance/ changes in laboratory parameters over time (study period) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Laboratory assessment includes hematology, biochemistry, coagulation, serology and urinanalysis

  • Body mass [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Change of Body mass over time (study period)

  • Neurological Examination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    New findings or change in pre-existing findings assessed in neurological examinations over time (study period)


Secondary Outcome Measures:
  • Immunological activity of AFFITOPE® vaccines PD01A and PD03A. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein

  • Change in motor symptoms at Visit 5 and Visit 8 compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in Motor symptoms: UMSARS II (Unified Multiple System Atrophy Rating Scale), CGI (Clinical Global Impression Improvement scale)

  • Change in non-motor symptoms at Visit 5 and Visit 8 compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in non-motor symptoms: UMSARS I and IV, GDS (Geriatric Depression Scale), COMPASS 31 (Composite Autonomic Symptom Score), MSA-QoL (MSA- Quality of life scale), MOCA (Montreal cognitive assessment), autonomic testing of cardiovascular function


Estimated Enrollment: 30
Study Start Date: November 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFFITOPE® PD01A + Adjuvant

4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks

1 boost immunization 36 weeks after first injection

Biological: AFFITOPE® PD01A + Adjuvant
s.c. injection
Experimental: AFFITOPE® PD03A + Adjuvant

4 injections of 75µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks

1 boost immunization 36 weeks after first injection

Biological: AFFITOPE® PD03A + Adjuvant
s.c. injection
Placebo Comparator: Adjuvant without active component

4 injections of Placebo once every 4 weeks

1 administration 36 weeks after first injection

Biological: Adjuvant without active component
s.c. injection

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Possible or probably MSA diagnosis (MSA-P or MSA-C) according to Gilman 2008 consensus criteria
  • Onset of MSA symptoms less than 4 years
  • Participants with an anticipated survival of at least 3 years in the opinion of the PI
  • Written informed consent obtained prior to study entry
  • MSA patient > 30 and < 75 years of age at time of study entry
  • Female patients of childbearing potential using a medically accepted contraceptive method
  • Stable medication for MSA symptoms (Levodopa, Dopamine agonists, Midodrine, Fludrocortisone, monoamine oxidase-B and Catechol-O-methyltransferase inhibitors; Antidepressants, Laxatives, NSAIDs or paracetamol as basic medication for pain in the musculoskeletal system)

Exclusion Criteria:

  • Pregnant or lactating women
  • Sexually active women of childbearing potential not using a medically accepted birth control method
  • Patients with dementia (MOCA at Screening < 21)
  • Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
  • Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
  • Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
  • History or evidence of any other central nervous system disorder like stroke, angioma and other relevant neurological diseases
  • History of malignancy other than skin cancer during the last 5 years (if considered to be cured, patient might be included)
  • Active or passive vaccination 4 weeks before the first vaccination on Day 0 and during the main study period ending on Day 280. Emergency vaccinations are acceptable
  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the entire study period
  • Subjects participating or have participated in another interventional clinical trial within 60 days prior to baseline
  • Blood donation within 4 weeks prior to first vaccination.
  • History of autoimmune diseases, severe hypersensitivity reactions and anaphylaxis, allergic bronchial asthma and severe allergic rhinoconjunctivitis
  • Known hypersensitivity or allergic reaction to one of the components of the vaccine
  • A family history of congenital or hereditary immunodeficiency
  • Administration of chronic (defined as more than 14 days) immunosuppressant or other immune-modifying drugs within six months before first vaccination and during the entire study period. For corticosteroids like prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed
  • Intake of non steroidal anti-inflammatory drugs (NSAIDs) or paracetamol more than the basic medication for pain in the musculoskeletal system within three days prior to a vaccination with AFFITOPE® PD01A or AFFITOPE® PD03A or Placebo
  • If a patient shows an acute febrile infection (≥ 37.8° Celsius) on the day of vaccination, administration of Investigational Medicinal Product (IMP) should be postponed until resolution of the infection
  • Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B (HBsAg) or Hepatitis C
  • Significant systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure and/or other deficiencies), if considered relevant by the investigator
  • Venous status rendering it impossible to place an i.v. access
  • Contraindications for MRI and lumbar puncture
  • Not able to understand and comply with protocol requirements, instructions, protocol-stated restrictions
  • Unwilling to provide informed consent. Exceptions for patients who are physically not able to provide written informed consent (e.g. legal representative, consent via voce with witness)
  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: NCT02270489

Contacts
Contact: AFFiRiS AG office@affiris.com

Locations
France
University Hospital Bordeaux (Pellegrin Hospital) Not yet recruiting
Bordeaux Cedex, France, 33076
Contact: Wassilios Meissner, MD, PhD    +33 557821424    wassilios.meissner@chu-bordeaux.fr   
Principal Investigator: Wassilios Meissner, Prof.         
University Hospital Toulouse Not yet recruiting
Toulouse Cedex 9, France, 31059
Contact: Olivier Rascol, MD, PhD    +33 561 77 91 03    olivier.rascol@univ-tlse3.fr   
Principal Investigator: Olivier Rascol, Prof.         
Sponsors and Collaborators
Affiris AG
Chu Hopitaux de Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Forschungszentrum Juelich
University Hospital, Toulouse
Investigators
Principal Investigator: Wassilios Meissner, MD, PhD University Hospital Bordeaux (Pellegrin Hospital), Bordeaux 33076, France
  More Information

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT02270489     History of Changes
Other Study ID Numbers: AFFiRiS 009, 2014-000567-40
Study First Received: September 4, 2014
Last Updated: November 19, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Neurodegenerative Diseases
Shy-Drager Syndrome
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Hypotension
Movement Disorders
Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014