Pityriasis Rubra PilarisPhase 4NCT07497620
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)
A Phase 4 study testing Bimekizumab in people with Pityriasis Rubra Pilaris, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris. 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?
- Bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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
- 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 Bimzelx
- Known history of hepatitis B, hepatitis C, or tuberculosis
- Personal or family history of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open Label, Exploratory Trial
The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
- Conditions
- Pityriasis Rubra Pilaris
- Being tested
- Bimekizumab
- 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.
BimekizumabDrug
Also called Bimzelx
Subjects will receive subcutaneous injection of 320 mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter for 24 weeks.
For patients weighing ≥ 120 kg, 320 mg every 4 weeks after Week 16, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bimzelx | Experimental | Patients will be treated with Bimzelx for pityriasis rubra pilaris, 320 mg, by subcutaneous injection. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks
The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement).
Measured: 24 weeks
Secondary outcomes (3)
Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks
The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement).
Measured: 28 weeks
Change in Physician Global Assessment (PGA) score
The Physician Global Assessment (PGA) is a clinician-reported 5 point scale used to evaluate overall disease activity. Ratings range from 0=clear (no signs of PRP, post-inflammatory pigmentation may be present); 1=almost clear (minimal plaque elevation, scaling or erythema); 2 =mild (slight plaque elevation, scaling, erythema); 3=moderate (moderate plaque elevation, scaling, and erythema); 4 =severe (very marked plaque elevation, scaling, and erythema)
Measured: Baseline, 28 weeks
Change in Dermatology Life Quality Index (DLQI) score
The Dermatology Life Quality Index (DLQI) consists of 10 standardized items measuring impact of skin disease rated as 0=not at all/not relevant; 1=a little; 2=a lot; 3=very much
Measured: Baseline, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497620
- Sponsor's protocol ID
- 25-010763
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open Label, Exploratory Trial
- ClinicalTrials.gov ID
- NCT07497620
- Acronym / sponsor ID
- 25-010763
- Conditions
- Pityriasis Rubra Pilaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (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 valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimzelx | Experimental | Drug: BimekizumabPatients will be treated with Bimzelx for pityriasis rubra pilaris, 320 mg, by subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 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 Bimzelx
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 |
|---|---|---|
| BimekizumabAlso: BimzelxSubjects will receive subcutaneous injection of 320 mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter for 24 weeks. For patients weighing ≥ 120 kg, 320 mg every 4 weeks after Week 16, for 24 weeks. | Drug | Bimzelx |
Primary outcome
Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks
Time frame: 24 weeks
The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement).
3 secondary outcomes
Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks
Time frame: 28 weeks
Change in Physician Global Assessment (PGA) score
Time frame: Baseline, 28 weeks
Change in Dermatology Life Quality Index (DLQI) score
Time frame: Baseline, 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Jason C. Sluzevich, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bimekizumab in people with Pityriasis Rubra Pilaris, run by Mayo Clinic at 1 site 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 7 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reagan Dukes (904-953-5144, dukes.reagan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks (time frame: 24 weeks). 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 8 Sep 2026.