A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

NCT04121221 | Completed Phase 3 FDA Drug

• 1 other identifier: Mapi GA Depot Phase III - 001
• Study Type: interventional
• Target: 1,016
• Locations: 10 countries
• Sites: 112

Brief Summary

A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; RMS; GA Depot; Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR)

  Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses.

  52 weeks

Secondary Outcomes (4)

• Changes in brain MRI (number of T1 lesions)

  52 weeks

• Changes in brain MRI (number of T2 lesions)

  52 weeks

• Hyperintense T2-lesion volume change

  52 weeks

• Enhancing T1-lesion volume change

  52 weeks

Study Arms (2)

GA Depot

EXPERIMENTAL

Monthly IM injection

Drug: GA Depot

Placebo

PLACEBO COMPARATOR

Monthly IM injection

Other: Placebo

Interventions

GA Depot DRUG

Long acting intramuscular injection of glatiramer acetate, once every 4 weeks

GA Depot

Placebo OTHER

IM injection once every 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult subjects between 18-55 years of age, inclusive.
• Subjects able to provide signed written informed consent.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
• MS diagnosis fulfilling the 2017 McDonald Criteria.
• Subjects should be ambulatory with an EDSS score of 0-5.5 at screening and baseline visits. EDSS score will be determined by a separate, blinded trained EDSS rater.
• Subjects should be relapse free and neurologically stable from one month before screening visit and from screening visit to baseline visit.
• No systemic corticosteroid treatment or ACTH within one month prior to screening visit.
• Subjects must have experienced at least one of the following:
• i. At least one documented relapse in the 12 months prior to screening. ii. At least two documented relapses in the 24 months prior to screening. iii. One documented relapse between 12 and 24 months prior to screening, with at least one documented T1-Gd enhancing lesion in MRI performed within 0-12 months before screening.
• Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visit and use an adequate contraceptive method throughout the study.

You may not qualify if:

• Use of experimental / investigational drug, and / or participation in drug clinical studies within the 6 months prior to screening.
• Any off-label drug use for MS treatment such as high dose simvastatin and biotin within 6 months prior to screening.
• Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent within 5 years.
• Previous use of Natalizumab or any anti-B cell agent within 9 months prior to screening.
• Previous use of Fingolimod or any other sphingosine-1-phosphate receptor modulator, Dimethyl Fumarate, Diroximel Fumarate (DRF), or Monomethyl fumarate within 2 months prior to screening. Subjects will be excluded if they do not have a lymphocyte count of above 1,000/mm3 at screening.
• Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used.
• Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
• Previous use of GA or any other glatiramoid.
• Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
• Previous total body irradiation or total lymphoid irradiation.
• Previous stem-cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation.
• Subjects with a clinically significant or unstable medical, psychiatric, or surgical conditions that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG and/or abnormal laboratory tests; and or subjects with an increased risk of serious Covid-19 related morbidity. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy, or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
• Subjects who have \>10 T1-Gd enhancing lesions at screening.
• A known history of sensitivity to Gadolinium.
• Inability to successfully undergo MRI scanning.

Sponsors & Collaborators

• Mapi Pharma Ltd.: lead

Study Sites (112)

Mapi Pharma Research site 08

Birmingham, Alabama, 35209, United States

Location

Mapi Pharma Research site 11

Cullman, Alabama, 35058, United States

Location

Mapi Pharma Research site 15

Pasadena, California, 91105, United States

Location

Mapi Pharma Research site 14

Denver, Colorado, 80209, United States

Location

Mapi Pharma Research site 12

Washington D.C., District of Columbia, 20007, United States

Location

Mapi Pharma Research site 17

Homestead, Florida, 33032, United States

Location

Mapi Pharma Research site 09

Miami, Florida, 33136, United States

Location

Mapi Pharma Research site 01

Northbrook, Illinois, 60062, United States

Location

Mapi Pharma Research site 02

Detroit, Michigan, 48201, United States

Location

Mapi Pharma Research site 13

Westerville, Ohio, 43081, United States

Location

Mapi Pharma Research site 04

Round Rock, Texas, 78681, United States

Location

Mapi Pharma Research site 02

Homyel, Belarus

Location

Mapi Pharma Research site 04

Minsk, Belarus

Location

Mapi Pharma Research site 05

Minsk, Belarus

Location

Mapi Pharma Research site 06

Minsk, Belarus

Location

Mapi Pharma Research site 01

Vitebsk, Belarus

Location

Mapi Pharma Research site 07

Vitebsk, Belarus

Location

Mapi Pharma Research site 04

Banja Luka, Bosnia and Herzegovina

Location

Mapi Pharma Research site 06

Bihać, Bosnia and Herzegovina

Location

Mapi Pharma Research site 01

Sarajevo, Bosnia and Herzegovina

Location

Mapi Pharma Research site 03

Tuzla, Bosnia and Herzegovina

Location

Mapi Pharma Research site 14

Haskovo, Bulgaria

Location

Mapi Pharma Research site 10

Pazardzhik, Bulgaria

Location

Mapi Pharma Research site 01

Pleven, Bulgaria

Location

Mapi Pharma Research site 02

Pleven, Bulgaria

Location

Mapi Pharma Research site 03

Pleven, Bulgaria

Location

Mapi Pharma Research site 07

Pleven, Bulgaria

Location

Mapi Pharma Research site 12

Plovdiv, Bulgaria

Location

Mapi Pharma Research site 18

Rousse, Bulgaria

Location

Mapi Pharma Research site 04

Sofia, Bulgaria

Location

Mapi Pharma Research site 05

Sofia, Bulgaria

Location

Mapi Pharma Research site 06

Sofia, Bulgaria

Location

Mapi Pharma Research site 08

Sofia, Bulgaria

Location

Mapi Pharma Research site 11

Sofia, Bulgaria

Location

Mapi Pharma Research site 13

Sofia, Bulgaria

Location

Mapi Pharma Research site 15

Sofia, Bulgaria

Location

Mapi Pharma Research site 16

Sofia, Bulgaria

Location

Mapi Pharma Research site 19

Sofia, Bulgaria

Location

Mapi Pharma Research site 09

Veliko Tarnovo, Bulgaria

Location

Mapi Pharma Research site 17

Vratsa, Bulgaria

Location

Mapi Pharma Research site 01

Tallinn, Estonia

Location

Mapi Pharma Research site 01

Tbilisi, Georgia

Location

Mapi Pharma Research site 02

Tbilisi, Georgia

Location

Mapi Pharma Research site 03

Tbilisi, Georgia

Location

Mapi Pharma Research site 04

Tbilisi, Georgia

Location

Mapi Pharma Research site 05

Tbilisi, Georgia

Location

Mapi Pharma Research site 06

Tbilisi, Georgia

Location

Mapi Pharma Research site 07

Tbilisi, Georgia

Location

Mapi Pharma Research site 08

Tbilisi, Georgia

Location

Mapi Pharma Research site 09

Tbilisi, Georgia

Location

Mapi Pharma Research site 01

Safed, Israel

Location

Mapi Pharma Research site 02

Tel Aviv, Israel

Location

Mapi Pharma Research site 01

Chisinau, Moldova

Location

Mapi Pharma Research site 02

Chisinau, Moldova

Location

Mapi Pharma Research site 29

Barnaul, Russia

Location

Mapi Pharma Research site 27

Bryansk, Russia

Location

Mapi Pharma Research site 23

Chelyabinsk, Russia

Location

Mapi Pharma Research site 01

Kazan', Russia

Location

Mapi Pharma Research site 19

Kemerovo, Russia

Location

Mapi Pharma Research site 24

Krasnodar, Russia

Location

Mapi Pharma Research site 03

Moscow, Russia

Location

Mapi Pharma Research site 13

Moscow, Russia

Location

Mapi Pharma Research site 14

Moscow, Russia

Location

Mapi Pharma Research site 21

Moscow, Russia

Location

Mapi Pharma Research site 25

Moscow, Russia

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Mapi Pharma Research site 28

Moscow, Russia

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Mapi Pharma Research site 02

Nizhny Novgorod, Russia

Location

Mapi Pharma Research site 07

Nizhny Novgorod, Russia

Location

Mapi Pharma Research site 10

Nizhny Novgorod, Russia

Location

Mapi Pharma Research site 11

Novosibirsk, Russia

Location

Mapi Pharma Research site 06

Perm, Russia

Location

Mapi Pharma Research site 22

Pyatigorsk, Russia

Location

Mapi Pharma Research site 08

Rostov-on-Don, Russia

Location

Mapi Pharma Research site 09

Saint Petersburg, Russia

Location

Mapi Pharma Research site 18

Saint Petersburg, Russia

Location

Mapi Pharma Research site 20

Saint Petersburg, Russia

Location

Mapi Pharma Research site 05

Samara, Russia

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Mapi Pharma Research site 26

Saransk, Russia

Location

Mapi Pharma Research site 15

Smolensk, Russia

Location

Mapi Pharma Research site 16

Tyumen, Russia

Location

Mapi Pharma Research site 04

Ufa, Russia

Location

Mapi Pharma Research site 17

Ulyanovsk, Russia

Location

Mapi Pharma Research site 32

Cherkasy, Ukraine

Location

Mapi Pharma Research site 06

Chernihiv, Ukraine

Location

Mapi Pharma Research site 11

Chernivtsi, Ukraine

Location

Mapi Pharma Research site 03

Dnipro, Ukraine

Location

Mapi Pharma Research site 04

Dnipro, Ukraine

Location

Mapi Pharma Research site 24

Dnipro, Ukraine

Location

Mapi Pharma Research site 18

Ivano-Frankivsk, Ukraine

Location

Mapi Pharma Research site 26

Ivano-Frankivsk, Ukraine

Location

Mapi Pharma Research site 27

Ivano-Frankivsk, Ukraine

Location

Mapi Pharma Research site 09

Kharkiv, Ukraine

Location

Mapi Pharma Research site 10

Kharkiv, Ukraine

Location

Mapi Pharma Research site 08

Kherson, Ukraine

Location

Mapi Pharma Research site 21

Kyiv, Ukraine

Location

Mapi Pharma Research site 25

Kyiv, Ukraine

Location

Mapi Pharma Research site 28

Kyiv, Ukraine

Location

Mapi Pharma Research site 29

Kyiv, Ukraine

Location

Mapi Pharma Research site 17

Lutsk, Ukraine

Location

Mapi Pharma Research site 12

Lviv, Ukraine

Location

Mapi Pharma Research site 13

Lviv, Ukraine

Location

Mapi Pharma Research site 23

Lviv, Ukraine

Location

Mapi Pharma Research site 05

Odesa, Ukraine

Location

Mapi Pharma Research site 14

Poltava, Ukraine

Location

Mapi Pharma Research site 34

Ternopil, Ukraine

Location

Mapi Pharma Research site 31

Uzhhorod, Ukraine

Location

Mapi Pharma Research site 16

Vinnitsa, Ukraine

Location

Mapi Pharma Research site 01

Zaporizhzhya, Ukraine

Location

Mapi Pharma Research site 02

Zaporizhzhya, Ukraine

Location

Mapi Pharma Research site 07

Zaporizhzhya, Ukraine

Location

Mapi Pharma Research site 20

Zaporizhzhya, Ukraine

Location

Mapi Pharma Research site 33

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Popper, MD

  Mapi Pharma Ltd.

  STUDY DIRECTOR

• Aaron E. Miller, Prof. MD

  Mount Sinai School of Medicine, New York, US

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the placebo controlled period subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times. Subjects who complete the PC period of the study will be offered to continue into the open label period for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: September 19, 2019
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

US (11); BE (6); BO (4); BU (19); MO (2); RU (28); ES (1); IL (2); UA (30); GE (9)