Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Other: Placebo; Drug: MEDI7352

Study type: Interventional

Funder types: Industry

Identifiers

NCT03755934

D5680C00002

2018-002523-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion criteria:

• 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).

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 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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

MEDl7352 Low Dose

Experimental group

Description:

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

Treatment:

Drug: MEDI7352

MEDl7352 Medium Dose

Experimental group

Description:

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

Treatment:

Drug: MEDI7352

MEDI7352 High Dose

Experimental group

Description:

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

Treatment:

Drug: MEDI7352