Treatment-resistant Pruritus Associated With Atopic DermatitisPhase 2NCT02004041

Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis

A Phase 2 study testing VLY-686 in people with Treatment-resistant Pruritus Associated With Atopic Dermatitis, run by Vanda Pharmaceuticals at 5 sites in Germany.

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

This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Treatment-resistant Pruritus Associated With Atopic Dermatitis
What is being tested?: VLY-686
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 5 sitesGermany
Study dates: 10 Dec 2013to 19 Feb 2015
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

Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck;
Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening;
Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits.

Who cannot join

Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid;
Acute superinfection of AD.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

Vanda Investigational Site
Düsseldorf, 40225
Vanda Investigational Site
Hamburg, 22083
Vanda Investigational Site
Jena, 07740
Vanda Investigational Site
Kiel, 24105
Vanda Investigational Site
Münster, 48147

Other trials in Germany

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof of Concept, Antipruritic Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis

Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
Being tested: VLY-686, Placebo
Keywords: pruritus, atopic dermatitis, VLY-686
Medical subject headings: Pruritus, Dermatitis, Atopic

What participants receive

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

VLY-686Drug
PlaceboDrug

Study groups in NCT02004041
Study group	Role	What they receive
VLY-686	Experimental	Not described Receives: Drug: VLY-686
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm).
Measured: 28 days

Timeline

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

10 Dec 201319 Feb 2015

First posted6 Dec 2013 (estimated)
Study start10 Dec 2013
Primary completion19 Feb 2015
Study completion19 Feb 2015

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 Treatment-resistant Pruritus Associated With Atopic DermatitisStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe 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: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02004041
Sponsor's protocol ID: VP-VLY-686-2101
Other IDs: 2013-002931-25
Status last verified: May 2024
First submitted: 21 Nov 2013
Last updated: 11 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof of Concept, Antipruritic Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
ClinicalTrials.gov ID: NCT02004041
Acronym / sponsor ID: VP-VLY-686-2101
Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
Keywords: pruritus, atopic dermatitis, VLY-686
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 10 Dec 2013 (actual)
Primary completion: 19 Feb 2015 (actual)
Study completion: 19 Feb 2015 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 11 Jun 2024

Clinical summary

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

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
VLY-686	Experimental	Drug: VLY-686
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck;
Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening;
Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits.

Key exclusion criteria (2 listed)

Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid;
Acute superinfection of AD.

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
VLY-686	Drug	VLY-686
Placebo	Drug	Placebo

Primary outcome

Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.
Time frame: 28 days
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm).

Results and safety

Results posted to the registry on 11 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VLY-686	34	30
Placebo	35	31

Primary outcome: Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.

Time frame: 28 days. Least squares mean (Standard Error). Unit: mm

Measure	VLY-686 n = 34	Placebo n = 33
Value	-40.5 (5.30)	-36.5 (4.96)

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VLY-686	0 of 34 (0%)	12 of 34 (35.3%)	0 of 34
Placebo	0 of 34 (0%)	11 of 34 (32.4%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

5 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 VLY-686 in people with Treatment-resistant Pruritus Associated With Atopic Dermatitis, run by Vanda Pharmaceuticals at 5 sites in Germany.

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 3 inclusion and 2 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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 11 Jun 2024). 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?

Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. (time frame: 28 days). 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 NCT02004041.

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 11 Jun 2024.