Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

September 6, 2023 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Research Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Research Site
      • Gdańsk, Poland, 80-382
        • Research Site
      • Katowice, Poland, 40-040
        • Research Site
      • Katowice, Poland, 40-282
        • Research Site
      • Kraków, Poland, 30-534
        • Research Site
      • Lublin, Poland, 20-093
        • Research Site
      • Lublin, Poland, 20064
        • Research Site
      • Olsztyn, Poland, 10117
        • Research Site
      • Poznań, Poland, 60-702
        • Research Site
      • Sochaczew, Poland, 96-500
        • Research Site
      • Toruń, Poland, 87100
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Warszawa, Poland, 01144
        • Research Site
      • Wrocław, Poland, 53-413
        • Research Site
  • Romania
      • Bucuresti, Romania, 011025
        • Research Site
      • Calarasi, Romania, 917080
        • Research Site
      • Craiova, Romania, 200505
        • Research Site
      • Galati, Romania, 800291
        • Research Site
      • Targu-Mures, Romania, 540142
        • Research Site
  • United Kingdom
      • Barnsley, United Kingdom, S75 3DL
        • Research Site
      • Blackpool, United Kingdom, FY2 0JH
        • Research Site
      • Cannock, United Kingdom, WS11 0BN
        • Research Site
      • Cardiff, United Kingdom, CF14 4XW
        • Research Site
      • Leeds, United Kingdom, LS10 1DU
        • Research Site
      • London, United Kingdom, NW10 7EW
        • Research Site
      • Manchester, United Kingdom, M13 9NQ
        • Research Site
      • Prescot, United Kingdom, L34 1BH
        • Research Site
      • Stockton-on-Tees, United Kingdom, TS17 6EW
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: Dose Level 1
MEDI7352
Biological: MEDI7352
MEDI7352
Experimental: Dose Level 2
MEDI7352
Biological: MEDI7352
MEDI7352
Experimental: Dose Level 3
MEDI7352
Biological: MEDI7352
MEDI7352
Experimental: Dose Level 4
MEDI7352
Biological: MEDI7352
MEDI7352

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the weekly average of the average daily pain scores
Time Frame: 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.
from the baseline week to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the weekly average of the average daily pain scores
Time Frame: 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).
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 scores
Time Frame: 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).
from baseline during Weeks 4, 8, and 12 of treatment and the week before follow-up (week 17).
Change in Galer Neuropathic Pain Scale (NPS)
Time Frame: 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).
from baseline to Days 28, 56, and 84 of treatment and the follow-up visit (week 18)
Change in Daily Sleep Interference Scale (DSIS)
Time Frame: 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).
from baseline to 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)
Time Frame: 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).
on Days 28, 56, and 84 of treatment and the follow-up visit (week 18).
Change in the 36-item Short-Form Health Survey (SF-36)
Time Frame: 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.
from baseline to Day 84 of treatment
Change in the amount of rescue medication used (in terms of dosage/day)
Time Frame: 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.
from baseline to Week 12 of treatment
incidence of AEs and SAEs
Time Frame: from baseline up to 18 weeks
from baseline up to 18 weeks
Area under the plasma concentration versus time curve of MEDI7352
Time Frame: from baseline up to 18 weeks
from baseline up to 18 weeks
Peak Plasma Concentration (Cmax) of MEDI7352
Time Frame: from baseline up to 18 weeks
from baseline up to 18 weeks
Summary of positive ADA against MEDI7352
Time Frame: from baseline up to 18 weeks
from baseline up to 18 weeks
To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN
Time Frame: 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.
from baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5680C00002

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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