Psoriasis VulgarisPhase 4NCT03331835
A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
A Phase 4 study testing Brodalumab and Fumaric acid esters in people with Psoriasis Vulgaris, run by LEO Pharma at 30 sites in Germany.
Trial summary
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Brodalumab and Fumaric acid esters
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 30 sitesGermany
- Study dates
- 3 Nov 2017to 21 Mar 2019
- Phase
- Phase 4
- 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
Main Criteria for Inclusion:
- Men or women ≥18 years of age at the time of screening.
- Subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation.
- Subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by PASI 10, affected BSA >10%, and DLQI >10.
- Subject has no known history of active tuberculosis.
- Subject has a negative test for tuberculosis taken at screening (negative Quantiferon test).
- Subject and/or subject's designee is/are capable of administering subcutaneous injections.
Main Criteria for Exclusion:
- Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
- Previous or current PUVA (psoralens and ultraviolet A) therapy.
- Washouts and non-permitted drugs:
- Have received phototherapy (UVA light therapy without psoralens, UVB light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or
- Have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids)
- Have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer
- Have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the IMP, whichever is longer.
- Subjects with any of the following laboratory abnormalities at screening:
- Leukocyte cell count below 3×10^9/L or lymphocyte count below 0.7×10^9/L
- Aspartate aminotransferase (AST) or alanine transferase (ALT) > 2× ULN (upper level of normal limit)
- Absolute neutrophil count < 2×10^9/L
- Serum creatinine > ULN.
- History of depressive disorder within the last 2 years including current antidepressive treatment.
- Subjects with a history of suicidal behaviour (suicide attempt).
- Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.
- A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Germany30 sites
Fachklinik Bad Bentheim Klinik für Dermatologie
Bad Bentheim, 48455
Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Psoriasis Studien Zentrum
Berlin, 10117
Rothhaar Studien GmbH Dermatologisches Studienzentrum
Berlin, 10783
Hautarztpraxis Dr. Wildfeuer
Berlin, 13055
Klinikum Bielefeld Klinik für Dermatologie und Allergologie
Bielefeld, 33647
Hauttumorzentrum Ruhr- Universität im St. Josef Hospital
Bochum, 44791
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus
Bochum, 44793
Universitätsklinikum Bonn (AöR) Klinik und Poliklinik für Dermatologie und Allergologie
Bonn, 53127
Elbe Klinikum Buxtehude Klinik für Dermatologie
Buxtehude, 21614
Rosenpark Research
Darmstadt, 64283
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
Dresden, 01307
Universitätsklinikum Erlangen Hautklinik
Erlangen, 91054
Universitätsklinikum Frankfurt Klinik für Dermatologie
Frankfurt, 60590
Derma-Study-Center-Friedrichshafen
Friedrichshafen, 88045
Gemeinschaftspraxis Rotterdam & Kollegen Facharzt für Haut & Geschlechtskrankheiten
Gelsenkirchen, 45883
Universitätsklinikum Hamburg-Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen
Hamburg, 20246
SCIderm GmbH
Hamburg, 20354
Medizinische Hochschule Hannover Klinik für Dermatologie Allergologie und Venerologie
Hanover, 30625
Universitäts-Hautklinik Heidelberg
Heidelberg, 69120
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein, Campus Kiel Psoriasis-Zentrum
Kiel, 24105
Exellenzzentrum Entzündungsmedizin (CCIM) Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
University Medical Center Mainz Department of Dermatology and Allergy, Clinical Research Center
Mainz, 55131
Universitätsklinikum Mannheim der Universität Heidelberg Klinik für Dermatologie, Venerologie und Allergologie
Mannheim, 68167
Technische Universität München Klinik und Poliklinik für Dermatologie und Allergologie
München, 80802
Klinische Forschung Osnabrück - Klifos
Osnabrück, 49074
KLINIKUM VEST GmbH Knappschaftskrankenhaus Recklinghausen Klinik für Dermatologie und Allergologie
Recklinghausen, 45657
Gemeinschaftspraxis Weber & Crainic
Schweinfurt, 97421
Hautarztpraxis Dres. Leitz
Stuttgart, 70178
University Medical Center University of Tübingen
Tübingen, 72076
Hautarztpraxis
Witten, 58453
About this study
Official title: A Phase 4 Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
Read the detailed description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
- Conditions
- Psoriasis Vulgaris
- Being tested
- Brodalumab, Fumaric acid esters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabBiological
Also called Kyntheum®
Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA).
Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis.
Fumaric acid estersDrug
Also called Fumaderm®
Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects.
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab | Experimental | Kyntheum® (brodalumab)
pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections.
First 3 injections are administered weekly, and hereafter every two weeks (Q2W). Receives: Biological: Brodalumab |
| Fumaric acid esters | Active comparator | Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)
Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)
Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label. Receives: Drug: Fumaric acid esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Measured: Baseline to Week 24
Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24
sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation.
Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
Measured: Baseline to Week 24
Secondary outcomes (11)
Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Measured: Baseline to Week 24
Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.
Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Measured: Baseline to Week 24
Change From Baseline at Week 24 in PASI Score
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative change in PASI score means that the PASI score was lower at the time of data collection.
Measured: Baseline to Week 24
Percent Change From Baseline in PASI Score at Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
A negative value in the percent change from baseline that the PASI score was lower at the time of data collection.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Affected Body Surface Area (BSA)
The surface area of the participant's hand (palm and fingers) is used as a reference measurement to calculate the percentage of each body region that is affected by psoriasis. One hand is approximately equal to 1% total BSA.
Furthermore, the complete body surface area (BSA=100%) can be divided into regions that approximates percentages of BSA as follows: head and neck (10%), upper extremities (20%), the trunk including the axillae and groin (30%), and finally the lower extremities, including the buttocks (40%).
A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection.
Measured: Baseline to Week 24
Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Measured: Week 24
PSI Total Score of 0 at Week 24
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Measured: Week 24
Number of Symptom-free Days From Randomisation to Week 24
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.
Measured: Baseline to Week 24
Burden of Symptoms
Burden of symptoms was assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment. The AUC for the PSI total score was calculated for each participant using the standard trapezoidal rule. The AUC was normalised by dividing it with the time from baseline to the last available assessment of the PSI total score.
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Measured: Baseline to Week 24
DLQI Total Score of 0 or 1 at Week 24
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Nov 2017
- Primary completion24 Jan 2019
- Study completion21 Mar 2019
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 Psoriasis VulgarisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331835
- Sponsor's protocol ID
- LP0160-1327
- Other IDs
- 2016-003867-21, 2016
- Status last verified
- Feb 2020
- First submitted
- 1 Nov 2017
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03331835
- Acronym / sponsor ID
- LP0160-1327
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 10 Feb 2020
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 is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
Detailed description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brodalumab | Experimental | Biological: BrodalumabKyntheum® (brodalumab) pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections. First 3 injections are administered weekly, and hereafter every two weeks (Q2W). |
| Fumaric acid esters | Active comparator | Drug: Fumaric acid estersFumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt) Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BrodalumabAlso: Kyntheum®Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA). Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis. | Biological | Brodalumab |
| Fumaric acid estersAlso: Fumaderm®Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects. | Drug | Fumaric acid esters |
Primary outcome
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24
Time frame: Baseline to Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24
Time frame: Baseline to Week 24
sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation. Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
11 secondary outcomes
Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24
Time frame: Baseline to Week 24
Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in PASI Score
Time frame: Baseline to Week 24
Percent Change From Baseline in PASI Score at Week 24
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Affected Body Surface Area (BSA)
Time frame: Baseline to Week 24
Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)
Time frame: Week 24
PSI Total Score of 0 at Week 24
Time frame: Week 24
Number of Symptom-free Days From Randomisation to Week 24
Time frame: Baseline to Week 24
Burden of Symptoms
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline to Week 24
DLQI Total Score of 0 or 1 at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Medical Expert study director
LEO Pharma
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brodalumab and Fumaric acid esters in people with Psoriasis Vulgaris, run by LEO Pharma at 30 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2020). 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?
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. 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 13 Mar 2025.