Trial Outcomes & Findings for ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis (NCT NCT01097668)

NCT ID: NCT01097668

Last Updated: 2015-02-16

Results Overview

Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 43 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2015-02-16

Participant Flow

Screening and study procedures were performed at hospital clinics within the United Kingdom and Russian Federation.

Subjects were human lymphocyte antigen (HLA)-DRB1*15 positive with relapsing-remitting multiple sclerosis as defined by the McDonald criteria and as assessed by a neurologist.

Participant milestones

Measure	Intradermal Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.	Subcutaneous Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
Overall Study STARTED	21	22
Overall Study Week 20	21	22
Overall Study Week 48	19	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Intradermal Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.	Subcutaneous Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

Baseline characteristics by cohort

Measure	Intradermal Injection n=21 Participants Injections of ATX-MS-1467 given by the intradermal route	Subcutaneous Injection n=22 Participants Injections of ATX-MS-1467 given by the subcutaneous route	Total n=43 Participants Total of all reporting groups
Age, Continuous	33.0 years n=5 Participants	31.6 years n=7 Participants	32.3 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Russian Federation	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: The Safety population will be denoted as the 'ITT population' for the summarisation of safety endpoints.

Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.

Outcome measures

Measure	Intradermal Injection n=21 Participants Injections of ATX-MS-1467 administered by the intradermal route	Subcutaneous Injection n=22 Participants Injections of ATX-MS-1467 administered by the subcutaneous route
Safety and Tolerability	21 participants	22 participants

SECONDARY outcome

Timeframe: 16 and 20 weeks

Population: ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection)

Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.

Outcome measures

Measure	Intradermal Injection n=21 Participants Injections of ATX-MS-1467 administered by the intradermal route	Subcutaneous Injection n=22 Participants Injections of ATX-MS-1467 administered by the subcutaneous route
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). ITT poulation at baseline	5.05 MRI lesions Interval 1.83 to 13.93	2.09 MRI lesions Interval 0.76 to 5.78
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). ITT population at Week 16	0.74 MRI lesions Interval 0.33 to 1.69	1.85 MRI lesions Interval 1.0 to 3.41
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). ITT population at Week 20	1.65 MRI lesions Interval 0.63 to 4.34	1.47 MRI lesions Interval 0.85 to 2.54
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). MRI population at baseline	3.41 MRI lesions Interval 1.08 to 10.75	2.3 MRI lesions Interval 0.79 to 6.71
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). MRI population at Week 16	0.73 MRI lesions Interval 0.28 to 1.89	1.71 MRI lesions Interval 0.93 to 3.14
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). MRI population at Week 20	1.51 MRI lesions Interval 0.48 to 4.73	1.20 MRI lesions Interval 0.68 to 2.14

Adverse Events

Intradermal Injection - Treatment Emergent

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Subcutaneous Injection - Treatment Emergent

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Intradermal Injection - Non Treatment Emergent

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Subcutaneous Injection - Non Treatment Emergent

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intradermal Injection - Treatment Emergent n=21 participants at risk Injections will be administered by the intradermal route	Subcutaneous Injection - Treatment Emergent n=22 participants at risk Injections will be administered by the subcutaneous route	Intradermal Injection - Non Treatment Emergent n=21 participants at risk Follow-up period	Subcutaneous Injection - Non Treatment Emergent n=22 participants at risk Follow-up period
Nervous system disorders Multiple Sclerosis Relapse	4.8% 1/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	9.5% 2/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.5% 1/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.

Other adverse events

Measure	Intradermal Injection - Treatment Emergent n=21 participants at risk Injections will be administered by the intradermal route	Subcutaneous Injection - Treatment Emergent n=22 participants at risk Injections will be administered by the subcutaneous route	Intradermal Injection - Non Treatment Emergent n=21 participants at risk Follow-up period	Subcutaneous Injection - Non Treatment Emergent n=22 participants at risk Follow-up period
General disorders Injection Site Reactions	57.1% 12/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	31.8% 7/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Infections and infestations Nasopharyngitis	14.3% 3/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.5% 1/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.8% 1/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.5% 1/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Infections and infestations Respiratory Tract Infection	9.5% 2/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.8% 1/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Nervous system disorders Headache	14.3% 3/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	13.6% 3/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	4.8% 1/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Nervous system disorders Multiple sclerosis relapse	9.5% 2/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	13.6% 3/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	19.0% 4/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	18.2% 4/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Musculoskeletal and connective tissue disorders Back Pain	9.5% 2/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	9.1% 2/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Skin and subcutaneous tissue disorders Rash pruritic	4.8% 1/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Immune system disorders Anti-peptide Antibody response	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/21 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.	0.00% 0/22 • Adverse event data collected over the course of the study = 52 weeks Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.

Additional Information

Chief Executive Officer

Apitope Technology (Bristol) Ltd

Phone: +44(0)117 3707720

Email: keith.martin@apitope.com

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