Atacicept in Subjects With Optic Neuritis

NCT00624468 | Terminated Phase 2 Results DMC

• 1 other identifier: 28156
• Study Type: interventional
• Target: 34
• Locations: 11 countries
• Sites: 28

Brief Summary

This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

Conditions

Optic Neuritis

Keywords

atacicept; neuritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)

  The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.

  Baseline, LOV (Week 48)

Secondary Outcomes (9)

• Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye

  Weeks 12, 24 and 36

• Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24

  Baseline, Weeks 12 and 24

• Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

  Baseline, Weeks 12, 24 and 36

• Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

  Baseline, Weeks 12, 24 and 36

• Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36

  Baseline, Weeks 12, 24 and 36

Study Arms (2)

Atacicept

EXPERIMENTAL

Drug: Atacicept

Placebo

PLACEBO COMPARATOR

Drug: Placebo matched to atacicept

Interventions

Atacicept DRUG

Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Atacicept

Placebo matched to atacicept DRUG

Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1

You may not qualify if:

• Pre treatment with immunosuppressants and immunomodulating drugs
• Relevant cardiac, hepatic and renal diseases
• Clinical significant abnormalities in blood cell counts and immunoglobulin levels
• Clinical significant acute or chronic infections

Sponsors & Collaborators

• EMD Serono: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (28)

Research Site

Birmingham, Alabama, United States

Location

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Aurora, Colorado, United States

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Fairfield, Connecticut, United States

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Jacksonville, Florida, United States

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East Lansing, Michigan, United States

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Philadelphia, Pennsylvania, United States

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Houston, Texas, United States

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Burlington, Vermont, United States

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Parkville, Victoria, Australia

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Brussels, Belgium

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Hradec Králové, Czechia

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Olomouc, Czechia

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Paris, France

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Freiburg im Breisgau, Germany

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Munich, Germany

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Tübingen, Germany

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Würzburg, Germany

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Beirut, Lebanon

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Dbaïyé, Lebanon

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Barcelona, Spain

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Seville, Spain

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Valencia, Spain

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Lausanne, Switzerland

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London, United Kingdom

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Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Optic Neuritis; Neuritis

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Limitations and Caveats

The Sponsor voluntarily terminated this trial after observing increased Multiple Sclerosis (MS) disease activity in trial 28063 (ATAMS).

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

  EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2011
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01

Locations

CZ (2); DE (4); BE (1); ES (3); US (8); FR (1); LE (2); GB (2); CH (1); AU (1); CA (3)