NCT04675034 (BESPOKE) is a Phase 2 clinical trial of MEDI7352 in Painful Osteoarthritis of the Knee, sponsored by AstraZeneca.

Who is sponsoring NCT04675034?

NCT04675034 is sponsored by AstraZeneca.

What drugs are being tested in NCT04675034?

Interventions in NCT04675034: MEDI7352, Placebo.

What condition does NCT04675034 study?

NCT04675034 studies Painful Osteoarthritis of the Knee.

Is NCT04675034 still recruiting?

NCT04675034 is currently completed. Last updated 10 February 2025.

Are results published for NCT04675034?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-10 · How we verify

NCT04675034: BESPOKE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee

Completed Phase 2 Results posted Last updated 10 February 2025

What this trial tests

Phase 2 trial testing MEDI7352 in Painful Osteoarthritis of the Knee in 345 participants. Completed in 16 August 2023.

Timeline

2 December 2020

Primary endpoint
16 August 2023

16 August 2023

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	345
Start date	2 December 2020
Primary completion	16 August 2023
Estimated completion	16 August 2023
Sites	41 locations across Denmark, Estonia, United Kingdom, Germany, Poland, Spain

Drugs / interventions tested

MEDI7352 — full drug profile →
Placebo

Conditions studied

Painful Osteoarthritis of the Knee — all drugs for Painful Osteoarthritis of the Knee →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 80, any sex, with Painful Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Weekly Average of Daily Numerical Rating Scale (NRS) Pain Score to Week 12 Primary · Baseline (Day -7 to Day -1, inclusive) through Week 12

Change from baseline in weekly average of daily NRS pain score to Week 12 is reported. The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This was recorded on a daily basis at approximately the same time every morning via electronic patient recorded outcome (ePRO) diary. A two-step multiple imputation procedure was used to address missing post-baseline scores.

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.19	± 2.243
MEDl7352 Dose Level 2	-3.00	± 2.342
MEDl7352 Dose Level 3	-2.83	± 2.522
MEDl7352 Dose Level 4	-2.81	± 2.835
Placebo	-2.35	± 2.364

Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale to Week 12 Secondary · Week 0 (Day 1; baseline) through Week 12

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to osteoarthritis (OA) in the target knee. Each question was scored on a NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain. Change from baseline in WOMAC pain subscale to Week 12 is reported. A two-step multiple imputation procedure was used to address missing

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.88	± 2.047
MEDl7352 Dose Level 2	-2.88	± 2.407
MEDl7352 Dose Level 3	-2.62	± 2.305
MEDl7352 Dose Level 4	-2.57	± 2.992
Placebo	-2.62	± 2.558

Change From Baseline in WOMAC Physical Function Subscale to Week 12 Secondary · Week 0 (Day 1; baseline) through Week 12

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC physical function (PF) subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC PF subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function. Change from baseline in WOMAC physical function to Week 12 is reported. A two-step mu

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.48	± 2.233
MEDl7352 Dose Level 2	-2.56	± 2.352
MEDl7352 Dose Level 3	-2.45	± 1.909
MEDl7352 Dose Level 4	-2.22	± 2.887
Placebo	-2.14	± 2.338

Change From Baseline in Patient's Global Assessment (PGA) of OA to Week 12 Secondary · Week 0 (Day 1; baseline) through Week 12

The PGA of OA was a 5-point Likert scale used to assess symptoms and activity impairment due to OA of the knee. Participants were asked to identify a number from 1 = "very good (asymptomatic and no limitation to normal activities)" to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)" based on the question "Considering all the ways that OA of the knee affects you, how are you feeling today?". Change from baseline in PGA of OA to Week 12 is reported. A two-step multiple imputation procedure was used to address missing post-baseline scor

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.34	± 0.933
MEDl7352 Dose Level 2	-0.72	± 1.123
MEDl7352 Dose Level 3	-0.81	± 1.032
MEDl7352 Dose Level 4	-0.69	± 1.377
Placebo	-0.57	± 1.003

Change From Baseline in WOMAC Pain Subscale Over Time Secondary · Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to OA in the target knee. Each question was scored on an NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain. Change from baseline in WOMAC pain subscale to Weeks 2, 4,6, 8, 10, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.32	± 1.501
MEDl7352 Dose Level 2	-1.79	± 1.988
MEDl7352 Dose Level 3	-1.58	± 1.571
MEDl7352 Dose Level 4	-1.88	± 1.953
Placebo	-1.30	± 1.968

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.62	± 1.635
MEDl7352 Dose Level 2	-2.33	± 2.230
MEDl7352 Dose Level 3	-2.41	± 1.939
MEDl7352 Dose Level 4	-2.60	± 2.077
Placebo	-2.08	± 2.000

Week 6

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.01	± 1.541
MEDl7352 Dose Level 2	-2.76	± 2.223
MEDl7352 Dose Level 3	-2.73	± 1.852
MEDl7352 Dose Level 4	-3.07	± 2.065
Placebo	-2.40	± 2.114

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.01	± 1.840
MEDl7352 Dose Level 2	-2.96	± 2.259
MEDl7352 Dose Level 3	-2.91	± 1.954
MEDl7352 Dose Level 4	-3.33	± 1.964
Placebo	-2.56	± 2.431

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.14	± 1.886
MEDl7352 Dose Level 2	-3.22	± 2.282
MEDl7352 Dose Level 3	-2.89	± 2.052
MEDl7352 Dose Level 4	-3.54	± 2.055
Placebo	-2.89	± 2.283

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.00	± 2.090
MEDl7352 Dose Level 2	-3.02	± 2.388
MEDl7352 Dose Level 3	-2.61	± 2.107
MEDl7352 Dose Level 4	-3.50	± 1.988
Placebo	-2.97	± 2.219

Change From Baseline in WOMAC PF Subscale Over Time Secondary · Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC PF subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC PF subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function. Change from baseline in WOMAC physical function to Weeks 2, 4, 6, 8, 10, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.06	± 1.621
MEDl7352 Dose Level 2	-1.64	± 1.877
MEDl7352 Dose Level 3	-1.56	± 1.417
MEDl7352 Dose Level 4	-1.80	± 1.778
Placebo	-0.96	± 1.728

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.59	± 1.812
MEDl7352 Dose Level 2	-2.07	± 1.933
MEDl7352 Dose Level 3	-2.20	± 1.701
MEDl7352 Dose Level 4	-2.39	± 2.062
Placebo	-1.62	± 1.708

Week 6

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.77	± 1.670
MEDl7352 Dose Level 2	-2.43	± 1.946
MEDl7352 Dose Level 3	-2.43	± 1.436
MEDl7352 Dose Level 4	-2.71	± 2.001
Placebo	-1.92	± 1.945

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.64	± 1.856
MEDl7352 Dose Level 2	-2.82	± 1.960
MEDl7352 Dose Level 3	-2.68	± 1.792
MEDl7352 Dose Level 4	-3.06	± 1.858
Placebo	-2.06	± 2.114

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.74	± 1.994
MEDl7352 Dose Level 2	-2.85	± 1.944
MEDl7352 Dose Level 3	-2.65	± 1.671
MEDl7352 Dose Level 4	-3.30	± 1.979
Placebo	-2.26	± 2.063

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.55	± 2.267
MEDl7352 Dose Level 2	-2.71	± 2.141
MEDl7352 Dose Level 3	-2.37	± 1.722
MEDl7352 Dose Level 4	-3.17	± 1.812
Placebo	-2.24	± 1.810

Change From Baseline in WOMAC Overall Score Over Time Secondary · Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), and 18 (Day 126)

The WOMAC overall score consisted of all 24 questions reported in the WOMAC questionnaire to assess: i) pain subscale, ii) PF subscale and iii) stiffness subscale. WOMAC overall score was calculated as the mean score from all 24 questions each scored on a Likert scale from 0 to 10 where higher scores represent worse outcome. Change from baseline in weekly average of WOMAC overall score to Weeks 2, 4, 6, 8, 10, 12, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.11	± 1.546
MEDl7352 Dose Level 2	-1.71	± 1.836
MEDl7352 Dose Level 3	-1.58	± 1.343
MEDl7352 Dose Level 4	-1.88	± 1.735
Placebo	-1.04	± 1.695

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.66	± 1.706
MEDl7352 Dose Level 2	-2.14	± 1.958
MEDl7352 Dose Level 3	-2.25	± 1.667
MEDl7352 Dose Level 4	-2.45	± 2.000
Placebo	-1.74	± 1.671

Week 6

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.85	± 1.583
MEDl7352 Dose Level 2	-2.54	± 1.968
MEDl7352 Dose Level 3	-2.52	± 1.426
MEDl7352 Dose Level 4	-2.79	± 1.951
Placebo	-1.98	± 1.984

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.75	± 1.792
MEDl7352 Dose Level 2	-2.85	± 1.995
MEDl7352 Dose Level 3	-2.69	± 1.757
MEDl7352 Dose Level 4	-3.12	± 1.822
Placebo	-2.19	± 2.102

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.86	± 1.907
MEDl7352 Dose Level 2	-2.94	± 1.995
MEDl7352 Dose Level 3	-2.72	± 1.663
MEDl7352 Dose Level 4	-3.35	± 1.954
Placebo	-2.43	± 2.022

Week 12

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.82	± 1.945
MEDl7352 Dose Level 2	-3.00	± 2.087
MEDl7352 Dose Level 3	-2.76	± 1.616
MEDl7352 Dose Level 4	-3.48	± 2.121
Placebo	-2.56	± 1.956

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.68	± 2.148
MEDl7352 Dose Level 2	-2.78	± 2.153
MEDl7352 Dose Level 3	-2.46	± 1.718
MEDl7352 Dose Level 4	-3.24	± 1.784
Placebo	-2.42	± 1.767

Change From Baseline in WOMAC Stiffness Scores Over Time Secondary · Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), and 18 (Day 126)

The WOMAC stiffness function subscale consists of 2 questions assessing stiffness due to OA in the target knee. Stiffness is defined as a sensation of decreased ease of movement in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC stiffness function subscale score is calculated as the mean score from the 2 questions, where higher scores represent higher stiffness. Change from baseline in WOMAC stiffness score to Weeks 2, 4, 6, 8, 10, 12, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.30	± 1.887
MEDl7352 Dose Level 2	-2.06	± 2.015
MEDl7352 Dose Level 3	-1.85	± 1.927
MEDl7352 Dose Level 4	-2.13	± 2.020
Placebo	-0.99	± 1.805

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.88	± 1.938
MEDl7352 Dose Level 2	-2.26	± 2.146
MEDl7352 Dose Level 3	-2.33	± 2.127
MEDl7352 Dose Level 4	-2.55	± 2.368
Placebo	-1.91	± 2.009

Week 6

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.13	± 1.837
MEDl7352 Dose Level 2	-2.79	± 2.307
MEDl7352 Dose Level 3	-2.72	± 1.871
MEDl7352 Dose Level 4	-2.97	± 2.428
Placebo	-2.27	± 2.314

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.99	± 2.125
MEDl7352 Dose Level 2	-2.85	± 2.260
MEDl7352 Dose Level 3	-2.85	± 2.103
MEDl7352 Dose Level 4	-3.07	± 2.104
Placebo	-2.39	± 2.633

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.13	± 2.060
MEDl7352 Dose Level 2	-2.99	± 2.277
MEDl7352 Dose Level 3	-2.96	± 1.977
MEDl7352 Dose Level 4	-3.29	± 2.091
Placebo	-2.67	± 2.329

Week 12

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.29	± 2.034
MEDl7352 Dose Level 2	-3.06	± 2.380
MEDl7352 Dose Level 3	-3.06	± 2.040
MEDl7352 Dose Level 4	-3.43	± 2.407
Placebo	-2.85	± 2.372

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.04	± 2.192
MEDl7352 Dose Level 2	-2.76	± 2.401
MEDl7352 Dose Level 3	-2.86	± 1.988
MEDl7352 Dose Level 4	-3.17	± 1.797
Placebo	-2.62	± 2.152

Change From Baseline in PGA of OA Over Time Secondary · Baseline, Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.35	± 0.812
MEDl7352 Dose Level 2	-0.56	± 0.917
MEDl7352 Dose Level 3	-0.67	± 0.933
MEDl7352 Dose Level 4	-0.42	± 1.059
Placebo	-0.37	± 0.698

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.48	± 0.738
MEDl7352 Dose Level 2	-0.68	± 1.066
MEDl7352 Dose Level 3	-0.86	± 1.043
MEDl7352 Dose Level 4	-0.86	± 1.106
Placebo	-0.48	± 0.792

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.57	± 0.910
MEDl7352 Dose Level 2	-0.80	± 1.026
MEDl7352 Dose Level 3	-1.02	± 1.090
MEDl7352 Dose Level 4	-1.04	± 1.098
Placebo	-0.51	± 0.843

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.42	± 0.723
MEDl7352 Dose Level 2	-0.76	± 0.922
MEDl7352 Dose Level 3	-1.02	± 1.010
MEDl7352 Dose Level 4	-1.06	± 1.295
Placebo	-0.67	± 0.826

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-0.39	± 0.655
MEDl7352 Dose Level 2	-0.66	± 1.022
MEDl7352 Dose Level 3	-0.83	± 1.117
MEDl7352 Dose Level 4	-1.10	± 1.294
Placebo	-0.56	± 0.700

Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Secondary · Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The OMERACT-OARSI responder index is calculated from the WOMAC Pain subscale, the WOMAC Physical Function Subscale and the PGA of OA. A participant is classified as a responder if: 1. \>= 2-point absolute change from Baseline to Week X or a \>= 50% improvement is reported in the WOMAC Pain or the PF subscales; 2. At least 2 of the following 3 conditions are true: \>= 1-point absolute change from Baseline to Week X or \>= 20% improvement is reported in the WOMAC Pain subscale, \>= 1-point absolute change from Baseline to Week X or \>= 20% improvement is reported in the WOMAC PF subscale or \>=

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	47.7
MEDl7352 Dose Level 2	62.5
MEDl7352 Dose Level 3	61.8
MEDl7352 Dose Level 4	59.7
Placebo	40.6

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	59.3
MEDl7352 Dose Level 2	67.7
MEDl7352 Dose Level 3	73.4
MEDl7352 Dose Level 4	65.6
Placebo	63.1

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	58.9
MEDl7352 Dose Level 2	80.7
MEDl7352 Dose Level 3	80.0
MEDl7352 Dose Level 4	86.3
Placebo	68.6

Week 12

Group	Value	95% CI
MEDl7352 Dose Level 1	59.2
MEDl7352 Dose Level 2	80.0
MEDl7352 Dose Level 3	80.0
MEDl7352 Dose Level 4	85.7
Placebo	67.4

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	55.3
MEDl7352 Dose Level 2	78.8
MEDl7352 Dose Level 3	72.2
MEDl7352 Dose Level 4	80.5
Placebo	70.2

Percentage of Participants With Improvement of >= 2 Points in PGA of OA Secondary · Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The PGA of OA was a 5-point Likert scale used to assess symptoms and activity impairment due to OA of the knee. Participants were asked to identify a number from 1 = "very good (asymptomatic and no limitation to normal activities)" to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)" based on the question "Considering all the ways that OA of the knee affects you, how are you feeling today?". Percentage of participants with improvement of \>= 2 points in PGA of OA at Weeks 2, 4, 8, 12, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	9.7
MEDl7352 Dose Level 2	9.7
MEDl7352 Dose Level 3	16.7
MEDl7352 Dose Level 4	12.3
Placebo	7.0

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	8.9
MEDl7352 Dose Level 2	26.7
MEDl7352 Dose Level 3	24.6
MEDl7352 Dose Level 4	22.0
Placebo	6.7

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	17.0
MEDl7352 Dose Level 2	23.6
MEDl7352 Dose Level 3	25.9
MEDl7352 Dose Level 4	28.6
Placebo	4.4

Week 12

Group	Value	95% CI
MEDl7352 Dose Level 1	10.9
MEDl7352 Dose Level 2	18.9
MEDl7352 Dose Level 3	20.4
MEDl7352 Dose Level 4	32.5
Placebo	7.3

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	2.3
MEDl7352 Dose Level 2	20.0
MEDl7352 Dose Level 3	22.9
MEDl7352 Dose Level 4	25.6
Placebo	4.7

Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Secondary · Baseline (Day -7 to Day -1, inclusive), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This will be recorded on a daily basis at approximately the same time every morning via ePRO diary. Change from baseline in weekly average of daily NRS to Weeks 2, 4, 6, 8, 10, and 18 is reported.

Week 2

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.62	± 1.704
MEDl7352 Dose Level 2	-1.86	± 1.949
MEDl7352 Dose Level 3	-1.97	± 2.012
MEDl7352 Dose Level 4	-2.26	± 2.129
Placebo	-1.10	± 1.811

Week 4

Group	Value	95% CI
MEDl7352 Dose Level 1	-1.88	± 1.653
MEDl7352 Dose Level 2	-2.50	± 2.163
MEDl7352 Dose Level 3	-2.68	± 2.177
MEDl7352 Dose Level 4	-2.65	± 2.333
Placebo	-1.66	± 1.854

Week 6

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.17	± 1.687
MEDl7352 Dose Level 2	-2.83	± 2.248
MEDl7352 Dose Level 3	-3.00	± 2.192
MEDl7352 Dose Level 4	-3.35	± 2.498
Placebo	-1.97	± 2.020

Week 8

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.27	± 1.736
MEDl7352 Dose Level 2	-2.91	± 2.084
MEDl7352 Dose Level 3	-3.09	± 2.205
MEDl7352 Dose Level 4	-3.45	± 2.365
Placebo	-2.18	± 2.274

Week 10

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.38	± 2.001
MEDl7352 Dose Level 2	-3.18	± 1.930
MEDl7352 Dose Level 3	-3.24	± 2.294
MEDl7352 Dose Level 4	-3.57	± 2.274
Placebo	-2.28	± 2.047

Week 18

Group	Value	95% CI
MEDl7352 Dose Level 1	-2.08	± 2.120
MEDl7352 Dose Level 2	-3.18	± 2.237
MEDl7352 Dose Level 3	-2.90	± 2.157
MEDl7352 Dose Level 4	-3.63	± 2.383
Placebo	-2.45	± 1.969

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 through 41 weeks (maximum observed duration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MEDI7352 Dose Level 1

Serious: 3/70 (4%)

Deaths: 0/70

MEDI7352 Dose Level 2

Serious: 5/68 (7%)

Deaths: 0/68

MEDI7352 Dose Level 3

Serious: 3/69 (4%)

Deaths: 0/69

MEDI7352 Dose Level 4

Serious: 1/68 (1%)

Deaths: 0/68

Placebo

Serious: 2/69 (3%)

Deaths: 0/69

Serious adverse events (21 terms)

Reaction	System	MEDI7352 Dose Level 1	MEDI7352 Dose Level 2	MEDI7352 Dose Level 3	MEDI7352 Dose Level 4	Placebo
Multiple injuries	Injury, poisoning and procedural complications	—	—	—	—	—
Splenic rupture	Injury, poisoning and procedural complications	—	—	—	—	—
Traumatic renal injury	Injury, poisoning and procedural complications	—	—	—	—	—
Liver function test abnormal	Investigations	—	—	—	—	—
Arthritis reactive	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Loss of bladder sensation	Renal and urinary disorders	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—
Urinoma	Renal and urinary disorders	—	—	—	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—	—	—	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	—	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—
Cardiovascular insufficiency	Cardiac disorders	—	—	—	—	—

Other adverse events (260 terms — click to expand)

Reaction	System	MEDI7352 Dose Level 1	MEDI7352 Dose Level 2	MEDI7352 Dose Level 3	MEDI7352 Dose Level 4	Placebo
Covid-19	Infections and infestations	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—
Joint injury	Injury, poisoning and procedural complications	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—
Facet joint syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Most-reported serious reactions: Multiple injuries, Splenic rupture, Traumatic renal injury, Liver function test abnormal, Arthritis reactive, Anaemia, Breast cancer, Gastrointestinal carcinoma.

Data from ClinicalTrials.gov NCT04675034 adverse events section.

Sponsor's own description

This is a Phase IIb randomised, double-blind, placebo-controlled, dose-response study in participants with painful osteoarthritis (OA) of the knee. The study will assess the safety and efficacy of multiple doses of MEDI7352 compared to placebo, as well as the pharmacokinetics, pharmacodynamics and immunogenicity of MEDI7352 in participants with moderate to severe chronic pain persistent for 3 months or more not adequately controlled by standard of care treatments.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Osteoarthritis Pain.
Yu H, Huang T, Lu WW, Tong L, et al · · 2022 · cited 93× · PMID 35563035 · DOI 10.3390/ijms23094642

Verify or expand the search:

Other trials of MEDI7352

Trials testing the same drug.

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NCT03755934 — Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy · Phase 2 · terminated

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04675034 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 10 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04675034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04675034: BESPOKE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (21 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of MEDI7352

Other AstraZeneca trials

Verify against primary sources