PITYRIASIS RUBRA PILARISPhase 1NCT03342573
Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris
A Phase 1 study testing Cosentyx in people with PITYRIASIS RUBRA PILARIS, run by Mayo Clinic at 2 sites in United States.
Trial summary
The primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PITYRIASIS RUBRA PILARIS
- What is being tested?
- Cosentyx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2018to 1 Feb 2022
- Phase
- Phase 1
- 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
- Informed subject consent will be obtained from those patients meeting the following inclusion criteria:
- Male and female patients 18 years or older.
- Clinical and/or histopathological diagnosis of PRP
- Candidate for systemic therapy (PASI ≥ 10)
- Body surface area of involvement ≥ 10%
- Good general health as confirmed by medical history
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Who cannot join
- Patients are to be excluded based on the following criteria:
- Vulnerable study population
- Pregnant or nursing women
- Women planning a pregnancy within the study period
- Human immunodeficiency virus (HIV) positivity
- Known history of adverse reaction to Cosentyx
- Known history of hepatitis B, hepatitis C, or tuberculosis
- Personal or family history of inflammatory bowel disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial
The primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.
- Conditions
- PITYRIASIS RUBRA PILARIS
- Being tested
- Cosentyx
- Medical subject headings
- Pityriasis Rubra Pilaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosentyxDrug
Also called Secukinumab
Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients with a biopsy proven diagnosis of PRP Receives: Drug: Cosentyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI-75
Psoriasis Area and Severity Index (PASI)-75 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 75%. As no formalized disease severity assessment scoring exists for PRP, the PASI score was selected given the phenotypic overlap between psoriasis and PRP
Measured: 28 weeks
Secondary outcomes (3)
PASI-90
PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90%
Measured: 28 weeks
DLQI
Dermatology Quality of Life Index - mean change before and after treatment
Measured: 28 weeks
PGA
Physician Global assessment - mean change before and after treatment
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2018
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PITYRIASIS RUBRA PILARISStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Sluzevich MD, Mayo Clinic
- Investigators
- Jason C Sluzevich, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342573
- Sponsor's protocol ID
- 16-006987
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2017
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boudreaux BW, Pincelli TP, Bhullar PK, Patel MH, Brumfiel CM, Li X, Heckman MG, Pittelkow MR, Mangold AR, Sluzevich JC. Secukinumab for the treatment of adult-onset pityriasis rubra pilaris: a single-arm clinical trial with transcriptomic analysis. Br J Dermatol. 2022 Nov;187(5):650-658. doi: 10.1111/bjd.21708. Epub 2022 Jul 15.
PubMed 35701384
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial
- ClinicalTrials.gov ID
- NCT03342573
- Acronym / sponsor ID
- 16-006987
- Conditions
- PITYRIASIS RUBRA PILARIS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 Nov 2017 (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 primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: CosentyxPatients with a biopsy proven diagnosis of PRP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed subject consent will be obtained from those patients meeting the following inclusion criteria:
- Male and female patients 18 years or older.
- Clinical and/or histopathological diagnosis of PRP
- Candidate for systemic therapy (PASI ≥ 10)
- Body surface area of involvement ≥ 10%
Key exclusion criteria (8 listed)
- Vulnerable study population
- Pregnant or nursing women
- Women planning a pregnancy within the study period
- Human immunodeficiency virus (HIV) positivity
- Known history of adverse reaction to Cosentyx
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 |
|---|---|---|
| CosentyxAlso: SecukinumabCosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks. | Drug | Single Arm |
Primary outcome
PASI-75
Time frame: 28 weeks
Psoriasis Area and Severity Index (PASI)-75 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 75%. As no formalized disease severity assessment scoring exists for PRP, the PASI score was selected given the phenotypic overlap between psoriasis and PRP
3 secondary outcomes
PASI-90
Time frame: 28 weeks
DLQI
Time frame: 28 weeks
PGA
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 35701384Boudreaux BW, Pincelli TP, Bhullar PK, Patel MH, Brumfiel CM, Li X, Heckman MG, Pittelkow MR, Mangold AR, Sluzevich JC. Secukinumab for the treatment of adult-onset pityriasis rubra pilaris: a single-arm clinical trial with transcriptomic analysis. Br J Dermatol. 2022 Nov;187(5):650-658. doi: 10.1111/bjd.21708. Epub 2022 Jul 15.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for PITYRIASIS RUBRA PILARIS
Not yet recruitingPhase 4
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)
Pityriasis Rubra Pilaris
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.
Jason C Sluzevich principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cosentyx in people with PITYRIASIS RUBRA PILARIS, run by Mayo Clinic 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 8 inclusion and 8 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 24 Feb 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PASI-75 (time frame: 28 weeks). 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 NCT03342573, 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 24 Feb 2022.