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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa

Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects with Moderate to Severe Hidradenitis Suppurativa

NCT ID

Therapeutic Area

SC injection at baseline, Week 4 and Week 8

Research Site

A Phase IIa Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of MEDI8968 in Subjects with Moderate to Severe Hidradenitis Suppurativa

Proportion of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12

Age Continuous

Gender, Male/Female

The trial terminated early due to lack of efficacy. An interim analysis was conducted after the first 61 subjects at 12 weeks and showed no evidence of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.  

Responders (%)

Non-responders (%)

Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12

Analysis of proportion of Responders for Physician’s Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF.  Difference in proportions MEDI8968 - placebo.  Wald asymptotic confidence limits calculated.

1) Percentage of subjects achieving a clinically relevant response in Physician Global Assessment (PGA), with score 0,1 or 2 from baseline to 12 weeks

Non-Responders (%)

Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are "minimally improved", "much improved" or "very much improved" on the Patient's Global Impression of Change (PGIC)

Difference in proportions MEDI8968 - placebo.  Wald asymptotic confidence limits calculated.

2) Subject’s global Impression of change reported on PGIC scale (1-7 point scale ranging from 1 "very much improved" to 7 "very much worse")

Week 4

Week 8

Week 12

Assessment of change in pain via Numerical Rating Scale.  Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. 
Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the
average of the values collected in the 7 days prior to that visit.


Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate

Change from baseline to 12 weeks in Numerical Assessment Scale Numerical Rating Scale for pain

Overall Study

Randomisation to treatment was stratified by PGA score on the day of randomisation (Stratum 1=PGA score of 3; Stratum 2=PGA score of 4 or 5).

Humphrey Gardner MD FCAP

Proportion of subjects achieving a clinically significant response measured by the proportion of subjects who are "minimally improved", "much improved" or "very much improved" on the Patient's Global Impression of Change (PGIC)

AEs, vital signs, laboratory assessments, ECG

Assessment of health related QoL via DLQI

Assessment of the proportion of patients achieving a reduction in average daily pain

Concentration of and exposure to MEDI8968 and development of anti-drug antibodies

Assessment of subjects achieving a clinically significant PGA response as measured by the proportion of subjects achieving at least a 2 step change in PGA

Arms	Assigned Interventions
Experimental: MEDI8968	Biological/Vaccine: MEDI8968 SC injection at baseline, Week 4 and Week 8 Other Name: Investigational Product
Placebo Comparator: Saline	Biological/Vaccine: Saline SC injection at baseline, Week 4 and Week 8 Other Name: Placebo

Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects with Moderate to Severe Hidradenitis Suppurativa

Official Title

Medical condition

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Documents available

Trial Results Summaries

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