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Multiple System AtrophyPhase 1AFF009NCT02270489

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

A Phase 1 study testing AFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant and Adjuvant without active component in people with Multiple System Atrophy and Neurodegenerative Diseases, run by Affiris AG at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
AFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant and Adjuvant without active component
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesFrance
Study dates
11 Dec 2014to 18 Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • University Hospital Bordeaux (Pellegrin Hospital)

    Bordeaux, 33076

  • University Hospital Toulouse

    Toulouse, 31059

Other trials in France

About this study

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

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).

Being tested
AFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant, Adjuvant without active component
Medical subject headings
Multiple System Atrophy, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFFITOPE® PD01A + AdjuvantBiological

    s.c. injection

  • AFFITOPE® PD03A + AdjuvantBiological

    s.c. injection

  • Adjuvant without active componentBiological

    s.c. injection

Study groups in NCT02270489
Study groupRoleWhat they receive
AFFITOPE® PD01A + AdjuvantExperimental4 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks 1 boost immunization 36 weeks after first injection
Receives: Biological: AFFITOPE® PD01A + Adjuvant
AFFITOPE® PD03A + AdjuvantExperimental4 injections of 75µg AFFITOPE® PD03A/ adjuvanted, once every 4 weeks 1 boost immunization 36 weeks after first injection
Receives: Biological: AFFITOPE® PD03A + Adjuvant
Adjuvant without active componentPlacebo comparator4 injections of Placebo once every 4 weeks 1 administration 36 weeks after first injection
Receives: Biological: Adjuvant without active component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who withdraw due to Adverse Events (AEs)

    Measured: 12 months

  2. Occurrence of Adverse Events and Serious Adverse Events

    Evaluation of Adverse Events and Serious Adverse Events in regards to autoimmune reactions

    Measured: 12 months

  3. Physical Examination

    New findings or change in pre-existing findings assessed in physical examinations over time (study period)

    Measured: 12 months

  4. Vital signs

    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).

    Measured: 12 months

  5. Safety related evaluation of MRI results of patients' brain after visit 5 and visit 8 compared to baseline

    Safety measures will e.g. include the occurrence of inflammatory reactions (meningoencephalitis), new/changed hemorrhages and lacunar infarcts.

    Measured: 12 months

  6. Clinical significance/ changes in laboratory parameters over time (study period)

    Laboratory assessment includes hematology, biochemistry, coagulation, serology and urinanalysis

    Measured: 12 months

  7. Body mass

    Change of Body mass over time (study period)

    Measured: 12 months

  8. Neurological Examination

    New findings or change in pre-existing findings assessed in neurological examinations over time (study period)

    Measured: 12 months

Secondary outcomes (3)

  1. Immunological activity of AFFITOPE® vaccines PD01A and PD03A.

    Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein

    Measured: 12 months

  2. Change in motor symptoms at Visit 5 and Visit 8 compared to baseline

    Change in Motor symptoms: UMSARS II (Unified Multiple System Atrophy Rating Scale), CGI (Clinical Global Impression Improvement scale)

    Measured: 12 months

  3. Change in non-motor symptoms at Visit 5 and Visit 8 compared to baseline

    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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study start11 Dec 2014
  3. Primary completion18 Apr 2017
  4. Study completion18 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270489
Sponsor's protocol ID
AFFiRiS 009
Other IDs
2014-000567-40, 2014
Acronym
AFF009
Status last verified
Jun 2017
First submitted
4 Sep 2014
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Meissner WG, Traon AP, Foubert-Samier A, Galabova G, Galitzky M, Kutzelnigg A, Laurens B, Luhrs P, Medori R, Peran P, Sabatini U, Vergnet S, Volc D, Poewe W, Schneeberger A, Staffler G, Rascol O; AFF009 Study Investigators. A Phase 1 Randomized Trial of Specific Active alpha-Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy. Mov Disord. 2020 Nov;35(11):1957-1965. doi: 10.1002/mds.28218. Epub 2020 Sep 3.

    PubMed 32882100

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant and Adjuvant without active component in people with Multiple System Atrophy and Neurodegenerative Diseases, run by Affiris AG at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who withdraw due to Adverse Events (AEs) (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.

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