PsoriasisPhase 2NCT01700985

A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

A Phase 2 study testing 122-0551 in people with Psoriasis and Plaque Psoriasis, run by Therapeutics, Inc. at 2 sites 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

Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis, Plaque Psoriasis
What is being tested?: 122-0551
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 2 sitesUnited States
Study dates: May 2012to Mar 2013
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

Subject has a clinical diagnosis of stable plaque psoriasis
Subject has an ODS score for the Treatment Area of 3 or 4 at study start

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 used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start

Show all 14Show fewer

Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
Subject is currently using lithium or Plaquenil (hydroxychloroquine)
Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
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 study start
Subject has been previously enrolled in this study and treated with a test article

Trial locations and contacts

2 sites in 1 country.

United States2 sites

DermResearch, Inc.
Austin, Texas, 78759
Therapeutics Clinical Research
San Diego, California, 92123

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Conditions: Psoriasis, Plaque Psoriasis
Being tested: 122-0551, Vehicle
Keywords: psoriasis, plaque psoriasis, 122-0551, steroid
Medical subject headings: Psoriasis

What participants receive

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

122-0551Drug
Applied twice daily for two weeks
VehicleDrug
Applied twice daily for two weeks

Study groups in NCT01700985
Study group	Role	What they receive
122-0551	Experimental	Not described Receives: Drug: 122-0551
Vehicle	Placebo comparator	Not described Receives: Drug: Vehicle

What is being measured

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

Change in Overall Disease Severity (ODS) Score
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Measured: baseline and Day 15 (End of Study - EOS)

Secondary outcomes (5)

ODS "Treatment Success" at Day 8 and Day 15
The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Measured: baseline, Day 8, and Day 15
ODS "Improved" at Day 8 and Day 15
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Measured: baseline, Day 8, and Day 15
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Measured: baseline, Day 8 and Day 15
"Improved" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Measured: baseline, Day 8 and Day 15
Change in % Body Surface Area (BSA) With Psoriasis
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Measured: baseline, Day 8 and Day 15

Timeline

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

May 2012Mar 2013

First posted4 Oct 2012 (estimated)
Study startMay 2012
Primary completionSep 2012
Study completionMar 2013

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01700985
Sponsor's protocol ID: 122-0551-203
Status last verified: Aug 2018
First submitted: 27 Sep 2012
Last updated: 25 Oct 2018
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 recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
ClinicalTrials.gov ID: NCT01700985
Acronym / sponsor ID: 122-0551-203
Conditions: Psoriasis, Plaque Psoriasis
Keywords: psoriasis, plaque psoriasis, 122-0551, steroid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Sep 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 25 Oct 2018

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
122-0551	Experimental	Drug: 122-0551
Vehicle	Placebo comparator	Drug: Vehicle

Who may qualify

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

Key inclusion criteria (2 listed)

Subject has a clinical diagnosis of stable plaque psoriasis
Subject has an ODS score for the Treatment Area of 3 or 4 at study start

Key exclusion criteria (14 listed)

Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start

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
122-0551Applied twice daily for two weeks	Drug	122-0551
VehicleApplied twice daily for two weeks	Drug	Vehicle

Primary outcome

Change in Overall Disease Severity (ODS) Score
Time frame: baseline and Day 15 (End of Study - EOS)
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.

5 secondary outcomes

ODS "Treatment Success" at Day 8 and Day 15
Time frame: baseline, Day 8, and Day 15
ODS "Improved" at Day 8 and Day 15
Time frame: baseline, Day 8, and Day 15
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
Time frame: baseline, Day 8 and Day 15
"Improved" for Clinical Signs and Symptoms of Psoriasis
Time frame: baseline, Day 8 and Day 15
Change in % Body Surface Area (BSA) With Psoriasis
Time frame: baseline, Day 8 and Day 15

Results and safety

Results posted to the registry on 25 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
122-0551	23	23
Vehicle	21	20

Primary outcome: Change in Overall Disease Severity (ODS) Score

Time frame: baseline and Day 15 (End of Study - EOS). Number. Unit: percentage of participants

Measure	122-0551 n = 23	Vehicle n = 20
Value	52.2	0.0

122-0551 vs Vehicle: p <0.0001, Fisher Exact

Population analysed: Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or early participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
122-0551	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Vehicle	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
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RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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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.

Syd Dromgoole, PhD study director

Therapeutics, Inc.

2 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 122-0551 in people with Psoriasis and Plaque Psoriasis, run by Therapeutics, Inc. at 2 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 2 inclusion and 14 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 25 Oct 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?

Change in Overall Disease Severity (ODS) Score (time frame: baseline and Day 15 (End of Study - EOS)). 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 NCT01700985.

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 25 Oct 2018.