ATX-MS-1467 in Multiple Sclerosis

NCT01973491 | Completed Phase 2 Results DMC

• 2 other identifiers: 200166-0012013-002916-28
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis (MS) and to assess the maintenance of any such effects.

Conditions

Multiple Sclerosis

Keywords

ATX-MS-1467 (MSC2358825A); Relapsing Multiple Sclerosis; Magnetic resonance imaging (MRI); M2736

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans

  T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.

  Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)

Secondary Outcomes (12)

• Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)

  Weeks 12, 16, 20, 24, 28 and 36

• Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36

  Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36

• Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36

  Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36

• Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions

  Weeks 12, 16, 20, 24, 28 and 36

• Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36

  Week 0, 12, 16, 20, 24, 28 and 36

Study Arms (1)

ATX-MS-1467

EXPERIMENTAL

Drug: ATX-MS-1467

Interventions

ATX-MS-1467 DRUG

Subjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.

Also known as: M2736, IL-10 Inducer

ATX-MS-1467

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent
• Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures
• Relapsing MS (relapsing-remitting multiple sclerosis \[RRMS\], secondary progressive multiple sclerosis \[SPMS\], as defined by the revised McDonald criteria \[2010\]) (11)
• Clinical evidence of recent MS activity and radiological activity on gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol
• Expanded disability status scale (EDSS) score 0-5.5
• Human leukocyte antigen-beta chain (HLA-DRB)1\*15 positive
• Neurological stability in the 30 days prior to Visit 5 (Study Day 1)
• Prior vaccination against tuberculosis (TB)
• If female, unless post-menopausal (for at least 2 years) or surgically sterilized, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467
• If male, must be willing to use two highly effective methods of contraception throughout the entire duration of the trial and for 90 days following the last dose of ATX-MS-1467

You may not qualify if:

• Primary progressive MS
• Inability to comply with MRI scanning, including contra-indications to MRI such as known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, nerve stimulators
• Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents
• Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467
• Use of any investigational drug or experimental procedure for MS (including cytokine or anticytokine therapy) within the 30 days prior to screening (Visit 1)
• Inadequate liver function as defined in the protocol.
• Lymphocyte count less than (\<)500 per micro liter (/mcL) or neutrophil count \< 1500 mcL at screening or at any of the pre-treatment visits (Visits 2-4)
• Major medical illness as defined in the protocol
• Known history of active or chronic infectious disease or any disease which compromises immune function
• Any renal condition that would preclude the administration of gadolinium
• History of malignancy, including both solid tumor and hematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved, in situ cervical cancer or prostatic cancer with normal prostatic specific antigen
• Clinical evidence of severe uncontrolled depression, active suicidal ideation or suicide attempt
• Any other significant medical or psychiatric conditions that, in the opinion of the Investigator, would preclude participation in the trial or impair the ability to give informed consent
• Major surgery in the 4 weeks prior to screening (Visit 1)
• Known hypersensitivity to the trial medication or diluents

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ATX-MS-1467

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 31, 2013
• Study Start: February 28, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: July 2, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-06

Locations

DE (1)