PruritusPhase 2SOOTHENCT03464526
A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
A Phase 2 study testing Orvepitant in people with Pruritus and Atopic Dermatitis, run by Nerre Therapeutics Ltd..
Trial summary
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Atopic Dermatitis
- What is being tested?
- Orvepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition
- Subjects must have chronic (> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines
- Subjects must have atopic dermatitis with a severity > 3 on the IGA and EASI ≥12 at Screening visit/Visit 1
Who cannot join
- Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus
- Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic
- Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2
- Inability to comply with the use of prohibited and allowed medications as described in the protocol.
About this study
Official title: A Double-Blind, Randomised, Placebo Controlled Study of the Efficacy and Safety and Pharmacokinetics of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.
Read the detailed description
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis.
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total).
All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.
- Conditions
- Pruritus, Atopic Dermatitis
- Being tested
- Orvepitant, Placebo
- 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.
OrvepitantDrug
Tablet, once daily, oral
PlaceboDrug
Tablet, once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Orvepitant 10mg | Active comparator | Orvepitant 10mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant |
| Orvepitant 20mg | Active comparator | Orvepitant 20mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant |
| Orvepitant 30mg | Active comparator | Orvepitant 30mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant |
| Placebo | Placebo comparator | Placebo tablet, once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Itch Intensity - Numeric Rating Scale
Change from baseline in the mean worst NRS pruritus intensity scores recorded by the subject during the last 3 days of available values in the period prior to the week 12 visit
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study startMay 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerre Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464526
- Sponsor's protocol ID
- ORV-ADP-01
- Acronym
- SOOTHE
- Status last verified
- May 2018
- First submitted
- 7 Mar 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo Controlled Study of the Efficacy and Safety and Pharmacokinetics of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03464526
- Acronym / sponsor ID
- SOOTHE / ORV-ADP-01
- Conditions
- Pruritus, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nerre Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
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 determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.
Detailed description
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis.
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total).
All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orvepitant 10mg | Active comparator | Drug: OrvepitantOrvepitant 10mg tablet, once daily for 12 weeks |
| Orvepitant 20mg | Active comparator | Drug: OrvepitantOrvepitant 20mg tablet, once daily for 12 weeks |
| Orvepitant 30mg | Active comparator | Drug: OrvepitantOrvepitant 30mg tablet, once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet, once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition
- Subjects must have chronic (> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines
- Subjects must have atopic dermatitis with a severity > 3 on the IGA and EASI ≥12 at Screening visit/Visit 1
Key exclusion criteria (4 listed)
- Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus
- Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic
- Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2
- Inability to comply with the use of prohibited and allowed medications as described in the protocol.
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 |
|---|---|---|
| OrvepitantTablet, once daily, oral | Drug | Orvepitant 10mg, Orvepitant 20mg, Orvepitant 30mg |
| PlaceboTablet, once daily, oral | Drug | Placebo |
Primary outcome
Change in Itch Intensity - Numeric Rating Scale
Time frame: Week 12
Change from baseline in the mean worst NRS pruritus intensity scores recorded by the subject during the last 3 days of available values in the period prior to the week 12 visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orvepitant in people with Pruritus and Atopic Dermatitis, run by Nerre Therapeutics Ltd..
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 4 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: withdrawn, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 in Itch Intensity - Numeric Rating Scale (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2018.