Affiris AG: Clinical Trials

16 completed, 3 terminated, 1 withdrawn. 12 Phase 1, 2 Phase 2.

By phase and status

Phase	Trials	Status
Phase 1	12	Completed 11, Withdrawn 1
Phase 2	2	Completed 1, Terminated 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA) AFFITOPE® PD01A - Parkinson's Disease	Phase 1	Completed	Affiris AG	26	2016-02-02	2017-06-05
Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects AFFITOPE® AT04A+adjuvant, AFFITOPE® AT06A+adjuvant, Adjuvant without active component - Hypercholesterolemia	Phase 1	Completed	Affiris AG	72	2015-07-01	2017-10-20
Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA AFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant, Adjuvant without active component - Multiple System Atrophy, Neurodegenerative Diseases	Phase 1	Completed	Affiris AG	30	2014-12-11	2017-06-05
Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease Low dose AFFITOPE® PD03A + Adjuvant, High dose AFFITOPE® PD03A + Adjuvant, Adjuvant without active component - Parkinson Disease, Neurodegenerative Diseases	Phase 1	Completed	Affiris AG	36	2014-12-01	2016-10-31
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity AFFITOPE® PD01A, Control - Parkinson's Disease	Phase 1	Completed	Affiris AG	28	2014-08-01	2015-08-17
Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006 AFFITOPE® AD02, Placebo - Alzheimer´s Disease	Phase 2	Terminated	Affiris AG	194	2013-06-01	2015-06-24
AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A Parkinson's Disease		Completed	Affiris AG	30	2013-06-01	2015-08-17
Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease AFFITOPE® PD01A, Control - Parkinson's Disease	Phase 1	Completed	Affiris AG	32	2012-02-01	2015-08-17
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A Alzheimer's Disease		Terminated	Affiris AG	16	2011-12-01	2013-11-06
Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease Alzheimer´s Disease		Terminated	Affiris AG	11	2011-07-01	2013-12-11
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP) ATH03 - HDL, Drug Safety	Phase 1	Completed	Affiris AG	36	2011-05-01	2012-10-05
Safety and Tolerability of AFFITOPE AD03 AFFITOPE AD03, AFFITOPE AD03 + Alum - Alzheimer's Disease	Phase 1	Completed	Affiris AG	28	2010-10-01	2011-12-20
AD01 Follow up Extension Visit Alzheimer´s Disease		Completed	Affiris AG	17	2010-09-01	2011-01-26
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease active: AFFITOPE AD02, control: Placebo - Alzheimer's Disease	Phase 2	Completed	Affiris AG	335	2010-09-01	2013-12-11
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02 AFFITOPE AD02 - Alzheimer's Disease	Phase 1	Completed	Affiris AG	20	2009-10-01	2010-10-19
Long-term Safety and Tolerability of AFFITOPE AD02 Alzheimer's Disease		Completed	Affiris AG	23	2008-11-01	2010-05-27
Long-term Safety and Tolerability of AFFITOPE AD01 Alzheimer's Disease		Completed	Affiris AG	22	2008-06-01	2010-05-27
Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease AFFITOPE AD02 - Alzheimer's Disease	Phase 1	Completed	Affiris AG	24	2008-02-01	2010-10-19
Tolerability and Safety of Subcutaneous Administration of Affitope AD01 in Mild to Moderate Alzheimer's Disease AFFITOPE AD01, AFFITOPE AD01 adjuvanted - Alzheimer's Disease	Phase 1	Completed	Affiris AG	24	2007-07-01	2010-10-19
Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients AFFITOPE® PD01A + Adjuvant, Adjuvant without active component - Parkinson's Disease	Phase 1	Withdrawn	Affiris AG			2016-08-05

Conditions studied

Alzheimer Disease (9)  ·  Parkinson Disease (6)  ·  Neurodegenerative Diseases (3)  ·  Brain Diseases (1)  ·  Dementia (1)  ·  Hypercholesterolemia (1)  ·  Inhibition, Psychological (1)  ·  Mental Disorders (1)  ·  Multiple System Atrophy (1)  ·  Nervous System Diseases (1)  ·  Tauopathies (1)

Interventions

Adjuvants, Pharmaceutic (4)  ·  aluminum sulfate (1)

Countries

Austria (18)  ·  France (3)  ·  Germany (3)  ·  Croatia (2)  ·  Czechia (2)  ·  Slovakia (2)

Top investigators

Dieter Volc, Prim. Dr. (4)  ·  Achim Schneeberger, MD (2)  ·  Siegfried Kasper, MD (2)  ·  Bruno Dubois, Prof (1)  ·  Bruno Dubois, Prof. (1)  ·  Dieter Volc, Prim, Dr. (1)  ·  Margot Schmitz, MD Univ. D. (1)  ·  Margot Schmitz, Univ. Doz. (1)  ·  Margot Schmitz, Univ. Doz. Dr. (1)  ·  Markus Mueller, Univ. Prof. (1)  ·  Markus Zeitlinger, MD (1)  ·  Peter Dal-Bianco, MD (1)  ·  Siegfried Kasper, Prof.Dr. (1)  ·  Thomas Gasser, Prof. Dr. (1)

Results publications

PMID 30741694, PMID 32882100, PMID 33969434, PMID 40953123

NIH funding

2014 (3), 2015 (2), 2009 (1), 2016 (1)