Moderate to Severe Chronic Plaque-type PsoriasisPhase 3NCT03504852
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis
A Phase 3 study testing secukinumab 150 mg in people with Moderate to Severe Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 67 sites in 7 countries.
Trial summary
The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Plaque-type Psoriasis
- What is being tested?
- secukinumab 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 67 sitesin 7 countries
- Study dates
- 25 Jun 2018to 15 Jul 2020
- 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
- Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations.
- Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study.
- Men or women at least 18 years of age at time of screening.
- Body weight of ≥ 90 kg at the time of randomization.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
- Moderate to severe psoriasis as defined at randomization by:
Show all 13Show fewer
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
- Investigator's Global Assessment (IGA) mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
- topical treatment and/or,
- phototherapy and/or,
- previous systemic therapy.
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
- Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- History of hypersensitivity to any of the study drug constituents.
Trial locations and contacts
67 sites in 7 countries.
67 sites in 7 countries
United States38 sites
Novartis Investigative Site
Alpharetta, Georgia, 30022
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Centennial, Colorado, 80111
Novartis Investigative Site
Charleston, South Carolina, 29414
Novartis Investigative Site
Charlotte, North Carolina, 28277
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
Fairborn, Ohio, 45324
Novartis Investigative Site
Forest Hills, New York, 11375
Novartis Investigative Site
Houston, Texas, 77056
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Irvine, California, 92697
Novartis Investigative Site
Louisville, Kentucky, 40241
Novartis Investigative Site
Madison, Wisconsin, 53717
Novartis Investigative Site
Mesquite, Texas, 75150
Novartis Investigative Site
New Albany, Indiana, 47150
Novartis Investigative Site
New Brighton, Minnesota, 55112
Novartis Investigative Site
New York, New York, 10025 1737
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Oregon City, Oregon, 97045
Novartis Investigative Site
Owensboro, Kentucky, 42303
Novartis Investigative Site
Pflugerville, Texas, 78660
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Rogers, Arkansas, 72758
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
Saint Joseph, Missouri, 64506
Novartis Investigative Site
San Antonio, Texas, 78218
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Santa Monica, California, 90404
Novartis Investigative Site
Skokie, Illinois, 60077
Novartis Investigative Site
Snellville, Georgia, 30078
Novartis Investigative Site
Tampa, Florida, 33612
Novartis Investigative Site
Verona, New Jersey, 07044
Novartis Investigative Site
Wenatchee, Washington, 98801
Novartis Investigative Site
West Palm Beach, Florida, 33409
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
Russia7 sites
Novartis Investigative Site
Chelyabinsk, 454092
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Lipetsk, 398005
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Yekaterinburg, 620023
Canada6 sites
Novartis Investigative Site
Calgary, Alberta, T2G 1B1
Novartis Investigative Site
Etobicoke, Ontario, M8X 1Y9
Novartis Investigative Site
Guelph, Ontario, N1L 0B7
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6
Novartis Investigative Site
Québec, G1V 4X7
Novartis Investigative Site
Red Deer, Alberta, T4N 6V7
Germany6 sites
Novartis Investigative Site
Bochum, 44793
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 20537
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Leipzig, 04103
Italy5 sites
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Perugia, PG, 06100
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Siena, SI, 53100
Hungary3 sites
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Pécs, 7623
Novartis Investigative Site
Szeged, H 6725
Czechia2 sites
Novartis Investigative Site
Nový Jičín, 741 01
Novartis Investigative Site
Prague, Prague 1, 11000
About this study
Official title: A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.
Read the detailed description
A 52-week multicenter, randomized, double-blind, parallel-group trial in 331 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.
This study consisted of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).
Subjects were randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.
In addition, subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index (PASI) 90 response at Week 16 were reassigned using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.
- Being tested
- secukinumab 150 mg
- Keywords
- psoriasis, secukinumab, immune-mediated systemic disease, papules, plaques, itching, weight
- Medical subject headings
- Psoriasis, Plaque, Amyloid, Pruritus, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumab 150 mgDrug
sub-cutaneous secukinumab prefilled syringe 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 300 mg every 2 weeks (Q2W) | Experimental | 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment. Receives: Drug: secukinumab 150 mg |
| Secukinumab 300 mg every 4 weeks (Q4W) | Active comparator | 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group. Receives: Drug: secukinumab 150 mg |
| Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) | Active comparator | 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16). Receives: Drug: secukinumab 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)
A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
Measured: 16 weeks
Secondary outcomes (2)
Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)
IGA mod 2011 was conducted for overall psoriatic disease. The IGA modified 2011 used in this study was static, i.e., it referred exclusively to the subject's disease state at the time of the assessments, and did not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. The scale has 0 (clear) as min and 4 (severe) as max, i.e., a higher score indicates more severity.
Measured: 16 weeks
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Measured: Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start25 Jun 2018
- Primary completion13 Sep 2019
- Study completion15 Jul 2020
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 Moderate to Severe Chronic Plaque-type PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504852
- Sponsor's protocol ID
- CAIN457A2324
- Other IDs
- 2015-004620-60, 2015
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2018
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Publications
Augustin M, Reich K, Yamauchi P, Pinter A, Bagel J, Dahale S, You R, Bruin G, Djimopoulos J, Paguet B, Charef P, Patekar M, Keefe D. Secukinumab dosing every 2 weeks demonstrated superior efficacy compared with dosing every 4 weeks in patients with psoriasis weighing 90 kg or more: results of a randomized controlled trial. Br J Dermatol. 2022 Jun;186(6):942-954. doi: 10.1111/bjd.20971. Epub 2022 Apr 8.
PubMed 34981829
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT03504852
- Acronym / sponsor ID
- CAIN457A2324
- Keywords
- psoriasis, secukinumab, immune-mediated systemic disease, papules, plaques, itching, weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 7 Jun 2021
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 assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.
Detailed description
A 52-week multicenter, randomized, double-blind, parallel-group trial in 331 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.
This study consisted of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).
Subjects were randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.
In addition, subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index (PASI) 90 response at Week 16 were reassigned using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 300 mg every 2 weeks (Q2W) | Experimental | Drug: secukinumab 150 mg2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment. |
| Secukinumab 300 mg every 4 weeks (Q4W) | Active comparator | Drug: secukinumab 150 mg2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group. |
| Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) | Active comparator | Drug: secukinumab 150 mg2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations.
- Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study.
- Men or women at least 18 years of age at time of screening.
- Body weight of ≥ 90 kg at the time of randomization.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
Key exclusion criteria (7 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
- Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| secukinumab 150 mgsub-cutaneous secukinumab prefilled syringe 150 mg | Drug | Secukinumab 300 mg every 2 weeks (Q2W), Secukinumab 300 mg every 4 weeks (Q4W), Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) |
Primary outcome
Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)
Time frame: 16 weeks
A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
2 secondary outcomes
Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)
Time frame: 16 weeks
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34981829Augustin M, Reich K, Yamauchi P, Pinter A, Bagel J, Dahale S, You R, Bruin G, Djimopoulos J, Paguet B, Charef P, Patekar M, Keefe D. Secukinumab dosing every 2 weeks demonstrated superior efficacy compared with dosing every 4 weeks in patients with psoriasis weighing 90 kg or more: results of a randomized controlled trial. Br J Dermatol. 2022 Jun;186(6):942-954. doi: 10.1111/bjd.20971. Epub 2022 Apr 8.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
67 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secukinumab 150 mg in people with Moderate to Severe Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 67 sites in 7 countries.
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 13 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: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Russia, Canada, Germany, Italy and 2 more countries. 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 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 7 Jun 2021). 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 Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set) (time frame: 16 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 NCT03504852, 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 11 Oct 2021.