Plaque PsoriasisPhase 3NCT02742441
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
A Phase 3 study testing 122-0551 Foam in people with Plaque Psoriasis, run by Therapeutics, Inc. at 21 sites in United States.
Trial summary
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- 122-0551 Foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2016to 16 Jun 2017
- Phase
- Phase 3
- 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
- Subject is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit.
- Subject has provided written informed consent.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- Females must be post-menopausal , surgically sterile or use an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.
Who cannot join
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to the Baseline Visit.
- Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to the Baseline Visit.
- Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value.
Show all 17Show fewer
- Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study which in the opinion of the investigator is thought to modify the subject's disease.
- Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the Baseline Visit.
- Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit.
- Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
- Subject has a history of sensitivity to any of the ingredients in the test articles.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
- Subject has been previously enrolled in this study and treated with a test article.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Site 07
Ann Arbor, Michigan, 48103
Site 09
Austin, Texas, 78746
Site 16
Brandon, Florida, 33511
Site 10
Carmel, Indiana, 46032
Site 15
Clearwater, Florida, 33756
Site 19
Denver, Colorado, 80220
Site 17
Encino, California, 91436
Site 14
Fort Smith, Arkansas, 72916
Site 04
Gahanna, Ohio, 43230
Site 01
Hot Springs, Arkansas, 71913
Site 20
Miami Lakes, Florida, 33014
Site 05
Nashville, Tennessee, 37215
Site 06
New Albany, Indiana, 47150
Site 21
Norfolk, Virginia, 23507
Site 11
North Miami Beach, Florida, 33162
Site 12
Pinellas Park, Florida, 33781
Site 13
Quincy, Massachusetts, 02169
Site 02
Saint Joseph, Missouri, 64506
Site 18
San Antonio, Texas, 78229
Site 03
Spokane, Washington, 99202
Site 08
Wilmington, North Carolina, 28405
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- 122-0551 Foam, Vehicle Foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
122-0551 FoamDrug
Topical Foam containing active drug
Vehicle FoamDrug
Topical Foam containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| 122-0551 Foam | Experimental | 122-0511 Foam, topically applied twice daily
Intervention: Drug: 122-0551 Foam Receives: Drug: 122-0551 Foam |
| Vehicle Foam | Placebo comparator | Vehicle Foam, topically applied twice daily
Intervention: Drug: Vehicle Foam Receives: Drug: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Day 15
Secondary outcomes (1)
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion27 Feb 2017
- Study completion16 Jun 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742441
- Sponsor's protocol ID
- 122-0551-310
- Status last verified
- Oct 2018
- First submitted
- 14 Apr 2016
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796.
PubMed 31424709
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
- ClinicalTrials.gov ID
- NCT02742441
- Acronym / sponsor ID
- 122-0551-310
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
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 |
|---|---|---|
| 122-0551 Foam | Experimental | Drug: 122-0551 Foam122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam |
| Vehicle Foam | Placebo comparator | Drug: Vehicle FoamVehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is male or non-pregnant female and is at least 18 years of age at the time of the Screening Visit.
- Subject has provided written informed consent.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas).
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Key exclusion criteria (17 listed)
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to the Baseline Visit.
- Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to the Baseline Visit.
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 |
|---|---|---|
| 122-0551 FoamTopical Foam containing active drug | Drug | 122-0551 Foam |
| Vehicle FoamTopical Foam containing no active drug | Drug | Vehicle Foam |
Primary outcome
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Time frame: Day 15
The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
1 secondary outcome
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31424709Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796.
- Individual participant dataSharing planned: Undecided
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 122-0551 Foam in people with Plaque Psoriasis, run by Therapeutics, Inc. at 21 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 6 inclusion and 17 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Nov 2018). 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?
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) (time frame: Day 15). 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 NCT02742441, which also lists 1 linked publication.
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 14 Nov 2018.