Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

• Sponsor: AstraZeneca (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03755934
• Collaborator: (none)
• Enrollment: 111
• Locations: 28
• Arms: 5
• Anticipated Duration (Months): 67.2
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy	Biological: MEDI7352; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double blind
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy
• Actual Study Start Date: Nov 19, 2018
• Anticipated Primary Completion Date: Jun 24, 2024
• Anticipated Study Completion Date: Jun 24, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Level 1 MEDI7352	Biological: MEDI7352; MEDI7352
Experimental: Dose Level 2 MEDI7352	Biological: MEDI7352; MEDI7352
Experimental: Dose Level 3 MEDI7352	Biological: MEDI7352; MEDI7352
Placebo Comparator: Placebo Placebo	Other: Placebo; Placebo
Experimental: Dose Level 4 MEDI7352	Biological: MEDI7352; MEDI7352

Outcome Measures

Primary Outcome Measures

1. Change in the weekly average of the average daily pain scores [from the baseline week to Week 12]

   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.

Secondary Outcome Measures

1. Change in the weekly average of the average daily pain scores [Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit (week 17).]

   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).

2. Change in the weekly average of the average daily pain scores [from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17).]

   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).

3. Change in Galer Neuropathic Pain Scale (NPS) [from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)]

   Change in Galer Neuropathic Pain Scale (NPS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18).

4. Change in Daily Sleep Interference Scale (DSIS) [from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)]

   Change in Daily Sleep Interference Scale (DSIS) from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18).

5. 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).]

   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).

6. Change in the 36-item Short-Form Health Survey (SF-36) [from baseline to Day 84 of treatment]

   Change in the 36-item Short-Form Health Survey (SF-36) from baseline to Day 84 of treatment.

7. Change in the amount of rescue medication used (in terms of dosage/day) [from baseline to Week 12 of treatment]

   Change in the amount of rescue medication used (in terms of dosage/day) from baseline to Week 12 of treatment.

8. incidence of AEs and SAEs [from baseline up to 18 weeks]

9. Area under the plasma concentration versus time curve of MEDI7352 [from baseline up to 18 weeks]

10. Peak Plasma Concentration (Cmax) of MEDI7352 [from baseline up to 18 weeks]

11. Summary of positive ADA against MEDI7352 [from baseline up to 18 weeks]

12. To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN [from baseline up to 12 weeks]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Gentofte		Denmark	2820
2	Research Site	Balatonfüred		Hungary	8230
3	Research Site	Bydgoszcz		Poland	85-065
4	Research Site	Katowice		Poland	40-040
5	Research Site	Katowice		Poland	40-282
6	Research Site	Lublin		Poland	20064
7	Research Site	Olsztyn		Poland	10117
8	Research Site	Rzeszow		Poland	35-302
9	Research Site	Sochaczew		Poland	96-500
10	Research Site	Toruń		Poland	87100
11	Research Site	Warszawa		Poland	01144
12	Research Site	Bucharest		Romania	020614
13	Research Site	Bucuresti		Romania	020475
14	Research Site	Bucuresti		Romania	022441
15	Research Site	Craiova		Romania	200505
16	Research Site	Galati		Romania	800001
17	Research Site	Ploiesti		Romania	107400
18	Research Site	Targu-Mures		Romania	540142
19	Research Site	Girona		Spain	17007
20	Research Site	Valladolid		Spain	47003
21	Research Site	Barnsley		United Kingdom	S75 3DL
22	Research Site	Blackpool		United Kingdom	FY2 0JH
23	Research Site	Cannock		United Kingdom	WS11 0BN
24	Research Site	Leeds		United Kingdom	LS10 1DU
25	Research Site	London		United Kingdom	NW10 7EW
26	Research Site	Manchester		United Kingdom	M13 9NQ
27	Research Site	Prescot		United Kingdom	L34 1BH
28	Research Site	Stockton-on-Tees		United Kingdom	TS17 6EW

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT03755934
• Other Study ID Numbers: D5680C00002
• First Posted: Nov 28, 2018
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetic Neuropathies; Pain

Study Results

No Results Posted as of Aug 22, 2022