ItchPhase 2NCT03239106

A Study Examining the Medication Apremilast as Treatment for Chronic Itch

A Phase 2 study testing Apremilast in people with Itch, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Chronic Itch is a debilitating condition affecting many people. Currently, there are no FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic arthritis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Itch
What is being tested?: Apremilast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2017to 19 Sep 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Key Inclusion Criteria: A subject who meets all of the following criteria may be included in the study:
Male and non-pregnant, non-lactating female subjects aged 18 years or older
Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline
Diagnosis of CIP for at least 6 weeks prior to screening
Willingness to avoid pregnancy or fathering of children
Ability and willingness to provide written informed consent

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Willing and able to comply with all study requirements and restrictions
Willing to not participate in any other interventional trial for the duration of their participation
Subjects must be in good health as determined by medical history, physical examination, electrocardiogram, clinical laboratory tests and vital signs
Failure of a course 2-week course of treatment with topical triamcinolone 0.1% ointment BID
Histopathological demonstration of skin eosinophils, mast cell activation, lymphocytic infiltration, and/or dermal edema

Who cannot join

Key Exclusion Criteria: A subject who meets any of the following criteria will be excluded from the study:
Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic dermatitis, psoriasis, etc.)
Patients with a prior diagnosis of excoriation disorder
Use of topical treatments for CIP (other than bland emollients) within 1 week of Baseline
Systemic immunosuppressive or immunomodulating drugs within 4 weeks of Baseline
Subjects with cytopenias at screening, defined as:

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Leukocytes < 3 × 109/L.
Neutrophils < lower limit of normal.
Lymphocytes < 0.5 × 109/L
Hemoglobin < 10 g/dL.
Platelets < 100 × 109/L.
Unwilling or unable to follow medication restrictions described in Section 5.6.3, or unwilling or unable to sufficiently washout from use of restricted medication
Under medical treatment for a skin disease with a therapy listed in the prohibited medications section that may influence the results of the study
Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless currently controlled and stable, including (but not limited to) the following: Positive for Hepatitis C antibody test (anti-HCF) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Positive for HIV (DUO test, p24 antigen)
Active malignancy
Active substance abuse or history of substance abuse within 6 months of screening
History (including family history) or current evidence of congenital long QT syndrome or known acquired QT prolongation
Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit
Subjects who had previously received apremilast
Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:
Serum creatinine > 1.5 mg/dL
Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal
Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound results.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University Division of Dermatology
St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: An Open Label Study of Apremilast in Chronic Idiopathic Pruritus

Read the detailed description

There is no FDA-approved medication for chronic idiopathic pruritus (CIP). Apremilast has demonstrated notable activity and is approved for treatment in other pruritic inflammatory skin conditions such as psoriasis. The drug is currently being investigated as therapy for atopic dermatitis. Additionally, the investigators have preliminary data to suggest that apremilast's anti-inflammatory properties may work via neuromodulation targeting neuronal cytokine pathways. The proposed study plans to assess the efficacy of apremilast 30 mg BID in the setting of CIP. Durable response to a medication is typically seen within one to two months of starting an efficacious medication in subjects who respond. Therefore, the investigators have designed this study to end at Week 16 to definitively determine efficacy and conclude the study with confidence with regard to both efficacy and failure.

Conditions: Itch
Being tested: Apremilast
Keywords: itch, pruritus, CIP
Medical subject headings: Pruritus

What participants receive

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

ApremilastDrug
Also called Otezla
Apremilast 30 mg BID daily

Study groups in NCT03239106
Study group	Role	What they receive
open label	Experimental	All participants will receive Apremilast 30 mg BID. Receives: Drug: Apremilast

What is being measured

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

Absolute NRS Itch Score at Week 16 (End of Treatment)
Participants will complete a Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week.
0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.
Measured: Week 16

Secondary outcomes (3)

Absolute DLQI at Week 16
Participants will complete a 10 question Dermatology Quality of Life survey at baseline through Week 16
The DLQI is a numerical scale that scores multiple parameters of skin symptoms on a scale from 0 to 30. 0-1 = no effect at all on a patient's life (most favorable clinical outcome and minimum score), 1-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20 = very large effect on patient's life, 21-30 = extremely large effect on patient's life (worse clinical outcome and maximum score).
Measured: Week 16
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18
Participants' itch will be measured utilizing the Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week.
0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.
Measured: Screening through Week 18 (follow up visit)
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18
Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.
Measured: Screening through Week 18 (follow up visit)

Timeline

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

1 Dec 201719 Sep 2019

First posted3 Aug 2017
Study start1 Dec 2017
Primary completion31 Oct 2018
Study completion19 Sep 2019

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 ItchStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Not applicable
Intervention model: Single group
Model description: open label
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03239106
Sponsor's protocol ID: CIP-ApremilastCC-10004
Status last verified: Jun 2021
First submitted: 28 Jul 2017
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study of Apremilast in Chronic Idiopathic Pruritus
ClinicalTrials.gov ID: NCT03239106
Acronym / sponsor ID: CIP-ApremilastCC-10004
Conditions: Itch
Keywords: itch, pruritus, CIP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Celgene Corporation
Study start: 1 Dec 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 19 Sep 2019 (actual)
First posted: 3 Aug 2017 (actual)
Results: Posted 20 Apr 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: open label

Arm	Type	Receives
open label	Experimental	Drug: ApremilastAll participants will receive Apremilast 30 mg BID.

Who may qualify

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

Key inclusion criteria (11 listed)

Key Inclusion Criteria: A subject who meets all of the following criteria may be included in the study:
Male and non-pregnant, non-lactating female subjects aged 18 years or older
Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline
Diagnosis of CIP for at least 6 weeks prior to screening
Willingness to avoid pregnancy or fathering of children

Key exclusion criteria (24 listed)

Key Exclusion Criteria: A subject who meets any of the following criteria will be excluded from the study:
Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic dermatitis, psoriasis, etc.)
Patients with a prior diagnosis of excoriation disorder
Use of topical treatments for CIP (other than bland emollients) within 1 week of Baseline
Systemic immunosuppressive or immunomodulating drugs within 4 weeks of Baseline

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
ApremilastAlso: OtezlaApremilast 30 mg BID daily	Drug	open label

Primary outcome

Absolute NRS Itch Score at Week 16 (End of Treatment)
Time frame: Week 16
Participants will complete a Numeric Rating Scale for itch (0 representing "no itching" through 10 representing "worst itch imaginable") will be recalled from prior 24 hours and the prior week. 0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10.

3 secondary outcomes

Absolute DLQI at Week 16
Time frame: Week 16
NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18
Time frame: Screening through Week 18 (follow up visit)
DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18
Time frame: Screening through Week 18 (follow up visit)

Results and safety

Results posted to the registry on 20 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label	10	3

Primary outcome: Absolute NRS Itch Score at Week 16 (End of Treatment)

Time frame: Week 16. Median (Inter-Quartile Range). Unit: Units on a scale

Measure	Open Label n = 10
24 Hour NRS Itch Score	7 (1.5 to 10)
1 Week NRS Itch Score	7.5 (2 to 9.25)

Population analysed: All patients met criteria for chronic pruritus of unknown origin.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected until the end of the study visit at Week 18 or earlier if the subject dropped out of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Limitations and caveats (from the sponsor): Due to the high dropout rate in this study a meaningful intent-to-treat analysis was not possible. Therefore, in addition, we attempted a last observation carried forward (LOCF) analysis as well.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Brian S. Kim, MD principal investigator

Washington University School of Medicine

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apremilast in people with Itch, run by Washington University School of Medicine at 1 site 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 11 inclusion and 24 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 20 Apr 2020). 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?

Absolute NRS Itch Score at Week 16 (End of Treatment) (time frame: Week 16). 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 NCT03239106.

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 13 Jul 2021.