Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy

NCT03755934 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: D5680C000022018-002523-42
• Study Type: interventional
• Target: 112
• Locations: 5 countries
• Sites: 31

Brief Summary

This is a study investigating the effect of MEDI7352 on chronic pain in participants 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. Participants will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weekly Average of Average Daily Pain Score to Week 12

  Change from baseline to Week 12 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point numerical rating scale (NRS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (electronic patient-reported outcome \[ePRO\]).

  Baseline (Day -7 to Day -1, inclusive) through Week 12

Secondary Outcomes (22)

• Change From Baseline in Weekly Average of Average Daily Pain Score

  Baseline (Day -7 to Day -1, inclusive), Weeks 2, 4, 6, 8, 10, and 18

• Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Average Daily Pain Score

  Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)

• Change From Baseline in Galer Neuropathic Pain Scale (NPS)

  Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)

• Change From Baseline in Daily Sleep Interference Scale (DSIS)

  Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)

• Percentage of Participants With 'Improved', 'Much Improved', or 'Very Much Improved' Status in Patient Global Impression of Change (PGIC)

  Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.

Other: Placebo

MEDl7352 Low Dose

EXPERIMENTAL

Participants received 6 doses of IV MEDl7352 low dose during 12-week treatment period.

Drug: MEDI7352

MEDl7352 Medium Dose

EXPERIMENTAL

Participants received 6 doses of IV MEDl7352 medium dose during 12-week treatment period.

Drug: MEDI7352

MEDI7352 High Dose

EXPERIMENTAL

Participants received 6 doses of IV MEDl7352 high dose during 12-week treatment period.

Drug: MEDI7352

Interventions

MEDI7352 DRUG

Participants will receive IV infusion of MEDI7352 as stated in arm description.

MEDI7352 High Dose; MEDl7352 Low Dose; MEDl7352 Medium Dose

Placebo OTHER

Participants will receive IV infusion of placebo as stated in arm description.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
• Body mass index of ≤ 42 kg/m\^2.
• Chronic painful diabetic neuropathy (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) numerical rating scale (NRS).
• Willing and able to discontinue all non-steroidal anti-inflammatory drug (NSAID) or cyclooxygenase-2 (COX-2) analgesic therapy.
• Currently be taking medication for the treatment of PDN. Participants should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN).

You may not qualify if:

• 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 osteoarthritis (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 participants 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 participant's PDN pain, as judged by the investigator.
• Haemoglobin A1C greater than 10.0% (\> 10.0%).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (31)

Research Site

Gentofte Municipality, 2820, Denmark

Location

Research Site

Balatonfüred, 8230, Hungary

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Budapest, 1036, Hungary

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Bydgoszcz, 85-065, Poland

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Gdansk, 80-382, Poland

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Katowice, 40-040, Poland

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Katowice, 40-282, Poland

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Krakow, 30-534, Poland

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Lublin, 20-093, Poland

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Lublin, 20064, Poland

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Olsztyn, 10117, Poland

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Poznan, 60-702, Poland

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Sochaczew, 96-500, Poland

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Torun, 87100, Poland

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Warsaw, 01-192, Poland

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Warsaw, 01144, Poland

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Wroclaw, 53-413, Poland

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Bucharest, 011025, Romania

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Călăraşi, 917080, Romania

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Craiova, 200505, Romania

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Galati, 800291, Romania

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Târgu Mureş, 540142, Romania

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Barnsley, S75 3DL, United Kingdom

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Blackpool, FY2 0JH, United Kingdom

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Cannock, WS11 0BN, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Leeds, LS10 1DU, United Kingdom

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London, NW10 7EW, United Kingdom

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Manchester, M13 9NQ, United Kingdom

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Prescot, L34 1BH, United Kingdom

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Stockton-on-Tees, TS17 6EW, United Kingdom

Location

Related Links

• CSR synopsis

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Limitations and Caveats

Dose-response relationship outcome was not evaluated by MCP-MOD because of insufficient number of doses. The study was prematurely terminated due to longer enrolment time than was anticipated. A combined population PK analysis was reported separately from the main CSR as a stand-alone report.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

+1-877-240-9479

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 28, 2018
• Study Start: November 19, 2018
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

DK (1); RO (5); HU (2); PL (14); GB (9)