Hidradenitis SuppurativaPhase 2NCT01838499

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

A Phase 2 study testing MEDI8968 and Saline in people with Hidradenitis Suppurativa, run by AstraZeneca at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hidradenitis Suppurativa
What is being tested?: MEDI8968 and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 27 sitesUnited States
Study dates: May 2013to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hidradenitis suppurativa (HS) (moderate to severe)
Diagnosis of HS for at least 1 year
At least 5 active inflammatory lesions in at least 2 locations
On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already taking these medications)
Average pain score of 3-9.

Who cannot join

History of cyclic neutropenia
Laboratory assessment abnormalities
Underlying disorder considered unsuitable for inclusion
Other skin diseases that may interfere with HS assessment
Pregnancy or planning for pregnancy

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Research Site
Arlington, Texas
Research Site
Atlanta, Georgia
Research Site
Bakersfield, California
Research Site
Chapel Hill, North Carolina
Research Site
Evansville, Indiana
Research Site
Forest Hills, New York
Research Site
Fremont, California
Research Site
Hershey, Pennsylvania
Research Site
High Point, North Carolina
Research Site
Indianapolis, Indiana
Research Site
Los Angeles, California
Research Site
Macon, Georgia
Research Site
Miami, Florida
Research Site
Norfolk, Virginia
Research Site
Orange Park, Florida
Research Site
Ormond Beach, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Rapid City, South Dakota
Research Site
Rockville, Maryland
Research Site
San Diego, California
Research Site
San Francisco, California
Research Site
Skokie, Illinois
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
West Dundee, Illinois
Research Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: 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

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

Conditions: Hidradenitis Suppurativa
Being tested: MEDI8968, Saline
Medical subject headings: Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI8968Biological
Also called Investigational Product
SC injection at baseline, Week 4 and Week 8
SalineBiological
Also called Placebo
SC injection at baseline, Week 4 and Week 8

Study groups in NCT01838499
Study group	Role	What they receive
MEDI8968	Experimental	Not described Receives: Biological: MEDI8968
Saline	Placebo comparator	Not described Receives: Biological: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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
Measured: 12 weeks

Secondary outcomes (2)

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")
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)
Measured: 12 weeks
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Oct 2014

First posted24 Apr 2013 (estimated)
Study startMay 2013
Primary completionOct 2014
Study completionOct 2014

Why it stopped: At the planned IA for decision making, no evidence was demonstrated of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01838499
Sponsor's protocol ID: D5440C00001
Status last verified: Jul 2016
First submitted: 19 Apr 2013
Last updated: 1 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01838499
Acronym / sponsor ID: D5440C00001
Conditions: Hidradenitis Suppurativa
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: At the planned IA for decision making, no evidence was demonstrated of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.
Enrolment: 224 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: ICON plc, Covance, PHT Corporation
Study start: May 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 1 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MEDI8968	Experimental	Biological: MEDI8968
Saline	Placebo comparator	Biological: Saline

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Hidradenitis suppurativa (HS) (moderate to severe)
Diagnosis of HS for at least 1 year
At least 5 active inflammatory lesions in at least 2 locations
On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already taking these medications)
Average pain score of 3-9.

Key exclusion criteria (5 listed)

History of cyclic neutropenia
Laboratory assessment abnormalities
Underlying disorder considered unsuitable for inclusion
Other skin diseases that may interfere with HS assessment
Pregnancy or planning for pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI8968Also: Investigational ProductSC injection at baseline, Week 4 and Week 8	Biological	MEDI8968
SalineAlso: PlaceboSC injection at baseline, Week 4 and Week 8	Biological	Saline

Primary outcome

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
Time frame: 12 weeks
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

2 secondary outcomes

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")
Time frame: 12 weeks
Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain
Time frame: 12 weeks

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MEDI8968	55	31
Saline	54	37

Primary outcome: 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

Time frame: 12 weeks. Number. Unit: % of patients

Measure	MEDI8968 n = 55	Saline n = 54
Responders (%)	23.6	18.5
Non-responders (%)	76.4	81.5

MEDI8968 vs Saline: Difference in proportions: 0.051 (80% CI -0.067 to 0.169), p >0.05, Mixed Models Analysis

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. However, if a subject withdraws from treatment for any reason prior to week 24, the subject should continue to be seen up to 16 weeks after his/her last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MEDI8968	2 of 55 (3.6%)	8 of 55 (14.5%)	Not reported
Saline	2 of 54 (3.7%)	2 of 54 (3.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hidradenitis Suppurativa

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert AK Lee, MD principal investigator

University of California, San Diego

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI8968 and Saline in people with Hidradenitis Suppurativa, run by AstraZeneca at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01838499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.