Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755934
• Other study ID #: D5680C00002
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2018
• Est. completion date: June 29, 2023

Study information

• Verified date: September 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful diabetic neuropathy. The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period. Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion criteria:

• Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
• Body mass index of =42 kg/m2.
• Chronic PDN persistent for 6 months or longer, not adequately controlled by standard of care treatments.
• mean pain intensity score of =4, as measured on an 11-point (0-10) NRS
• willing and able to discontinue all NSAID or COX-2 analgesic therapy
• currently be taking medication for the treatment of PDN. Subjects should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN)

Key Exclusion criteria:

• Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator.
• History of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
• Diagnosis of clinically significant OA currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in subjects for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.
• Chronic pain condition, other than PDN, that is likely to interfere with the evaluation of the subject's PDN pain, as judged by the investigator
• Haemoglobin A1C greater than 8.5% (>8.5%).

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Biological:
• MEDI7352
MEDI7352

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Research Site	Gentofte
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Sochaczew
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Romania	Research Site	Bucuresti
Romania	Research Site	Calarasi
Romania	Research Site	Craiova
Romania	Research Site	Galati
Romania	Research Site	Targu-Mures
United Kingdom	Research Site	Barnsley
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Cannock
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Prescot
United Kingdom	Research Site	Stockton-on-Tees

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Hungary,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the weekly average of the average daily pain scores	Change in the weekly average of the average daily pain scores from the baseline week to Week 12 of MEDI7352 compared to placebo, as measured on an 11-point (0-10) NRS.	from the baseline week to Week 12
Secondary	Change in the weekly average of the average daily pain scores	Change in the weekly average of the average daily pain score, as measured on an 11-point (0-10) NRS, from baseline to Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit (week 17).	Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit (week 17).
Secondary	Change in the weekly average of the average daily pain scores	Percentage of subjects who have achieved =30% and =50% reductions in the weekly average of the average daily pain score from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17).	from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17).
Secondary	Change in Galer Neuropathic Pain Scale (NPS)	Change in Galer Neuropathic Pain Scale (NPS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18).	from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)
Secondary	Change in Daily Sleep Interference Scale (DSIS)	Change in Daily Sleep Interference Scale (DSIS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18).	from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)
Secondary	Proportion of subjects who have 'improved', 'much improved,' or 'very much improved' relative to baseline on the Patient Global Impression of Change (PGIC)	Proportion of subjects who have 'improved', 'much improved,' or 'very much improved' relative to baseline on the Patient Global Impression of Change (PGIC) on Days 28, 56, and 84 of treatment and the follow-up visit (week 18).	on Days 28, 56, and 84 of treatment and the follow-up visit (week 18).
Secondary	Change in the 36-item Short-Form Health Survey (SF-36)	Change in the 36-item Short-Form Health Survey (SF-36) from baseline to Day 84 of treatment.	from baseline to Day 84 of treatment
Secondary	Change in the amount of rescue medication used (in terms of dosage/day)	Change in the amount of rescue medication used (in terms of dosage/day) from baseline to Week 12 of treatment.	from baseline to Week 12 of treatment
Secondary	incidence of AEs and SAEs		from baseline up to 18 weeks
Secondary	Area under the plasma concentration versus time curve of MEDI7352		from baseline up to 18 weeks
Secondary	Peak Plasma Concentration (Cmax) of MEDI7352		from baseline up to 18 weeks
Secondary	Summary of positive ADA against MEDI7352		from baseline up to 18 weeks
Secondary	To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN	Change in the weekly average of the average daily pain scores from the baseline week to Week 12, as measured on an 11-point (0-10) NRS, versus dose.	from baseline up to 12 weeks