Plaque PsoriasisPhase 4STEPinNCT03020199
Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis
A Phase 4 study testing Secukinumab and nb-UVB in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 44 sites in 13 countries.
Trial summary
The purpose of this study was to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Secukinumab and nb-UVB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 44 sitesin 13 countries
- Study dates
- 27 Mar 2017to 16 Jun 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed.
- Aged 18 to 50 years inclusive.
- New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arm A1, Arm A2, and Arm B1). Episodes of mild psoriasis, which occurred at least 3 years before screening and resolved spontaneously within 6 months will be accepted.
- Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2).
- Moderate to severe plaque psoriasis defined at screening and baseline by PASI >= 10, and body surface area (BSA) >= 10%, and IGA mod 2011 >= 3.
Who cannot join
- Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced).
- Ongoing use of prohibited treatments.
- Previous treatment with phototherapy or any systemic treatment.
- Pregnant or nursing (lactating) women.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment period or longer if required by locally approved prescribing information (e.g., 20 weeks in the EU and countries where applicable for secukinumab).
Trial locations and contacts
44 sites in 13 countries.
44 sites in 13 countries
Spain10 sites
Novartis Investigative Site
Alcorcón, Madrid, 28922
Novartis Investigative Site
Alicante, Valencia, 03010
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Las Palmas de Gran Canaria, 35010
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Valencia, Valencia, 46014
Poland6 sites
Novartis Investigative Site
Bialystok, 15-879
Novartis Investigative Site
Bydgoszcz, 85-094
Novartis Investigative Site
Gdansk, 80-803
Novartis Investigative Site
Krakow, 31-070
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Lodz, 90-647
Bulgaria5 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Sofia, 1407
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1632
Germany4 sites
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60590
United Kingdom4 sites
Novartis Investigative Site
Bradford, West Yorkshire, BD5 0NA
Novartis Investigative Site
Leeds, West Yorkshire, LS7 4SA
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Salford, M6 8HD
Estonia3 sites
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 50406
Argentina2 sites
Novartis Investigative Site
Buenos Aires, C1425DKG
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, 1181
Canada2 sites
Novartis Investigative Site
Greater Sudbury, Ontario, P3C 1X8
Novartis Investigative Site
Markham, Ontario, L3P 1X2
Finland2 sites
Novartis Investigative Site
Tampere, 33100
Novartis Investigative Site
Turku, FIN-20100
Hungary2 sites
Novartis Investigative Site
Nyíregyháza, 4400
Novartis Investigative Site
Szolnok, 5000
Sweden2 sites
Novartis Investigative Site
Gothenburg, 413 46
Novartis Investigative Site
Malmö, 214 28
About this study
Official title: A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)
The purpose of this study was to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).
Read the detailed description
This was and open label, parallel group, multicenter, randomized study with 3 clinical periods: Screening period, Treatment period, and Follow-up period.
The design consisted of the Main Study and a Mechanistic Sub study:
- The Main Study had 2-treatment-arm secukinumab and nb-UVB).
- The Mechanistic Sub-study had 4 arms treated with secukinumab and one arm with nb-UVB arm. The outcome measures were all exploratory, i.e. no results presented. Not all participants of the Mechanistic Sub-study participated in the Main Study, these participants are only reported for the safety analyses, but not for the primary and secondary outcome measures.
- Conditions
- Plaque Psoriasis
- Being tested
- Secukinumab, nb-UVB
- Keywords
- Psoriasis, interleukin (IL) 17A, IL-17A, secukinumab, AIN457, Narrow-band ultraviolet light B, nb-UVB, Psoriasis area and severity index, PASI
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Also called AIN457
Secukinumab (AIN457) 300 mg was administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose was provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe was labeled as AIN457 150 mg/1 mL.
nb-UVBRadiation
Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application was performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face was recommended
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 300 mg | Experimental | In the Main Study, 80 new-onset psoriasis patients in Arm A1 (68 in Arm A1a, 12 in Arm A1b) received 300 mg secukinumab injections weekly for the first month, then every 4 weeks until Week 48 (52-week treatment). Arm A1b patients also joined the Mechanistic Sub-study.
In the Mechanistic Sub-study, 12 new-onset psoriasis patients (Arm A2) and 24 chronic plaque psoriasis patients (12 each in Arms C1 and C2) received similar secukinumab treatment. Arm A2 and C2 patients continued until Week 100 (104-week treatment), while Arm C1 ended at Week 48 (52-week treatment). Receives: Biological: Secukinumab |
| Narrow-band ultraviolet B (nb-UVB) | Active comparator | In the Main Study, 80 new-onset psoriasis patients in Arm B1 (68 in Arm B1a and 12 in Arm B1b) received 1 or 2 cycles of nb UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 did not receive a second treatment cycle) (treatment duration = 52 weeks).
Patients from Arm B1b participated also in the Mechanistic Sub-study. Receives: Radiation: nb-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52.
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.
Measured: Baseline, Week 52
Secondary outcomes (2)
Number of Participants Who Achieved PASI 90 at Week 104
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 104, relative to baseline PASI score.
Measured: Baseline, Week 104
Number of Participants With IGA Mod 2011 0/1 Response at Week 52
Investigators assessed the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rated the disease from a score of 0 (clear skin) to 4 (severe disease). Response is defined as a score of 0 or 1 at Week 52.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start27 Mar 2017
- Primary completion30 Nov 2021
- Study completion16 Jun 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for Plaque 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 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
- NCT03020199
- Sponsor's protocol ID
- CAIN457A2322
- Other IDs
- 2015-002423-26, 2015
- Acronym
- STEPin
- Status last verified
- Jan 2025
- First submitted
- 23 Sep 2016
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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
Gudjonsson JE, Bier K, Gaulis S, Tsoi LC, Cardner M, Sarkar MK, Coon A, Cole C, Karner J, Fernandez A, Peters T, Eidsmo L, Iversen L, Jagiello P, Ferrero E, Kolbinger F, Lohmann F, Conrad C. Early intervention with secukinumab prevents epigenetic scar development in new-onset psoriasis: STEPIn mechanistic substudy results. J Allergy Clin Immunol. 2026 May 25:S0091-6749(26)00367-2. doi: 10.1016/j.jaci.2026.04.028. Online ahead of print.
PubMed 42191094Iversen L, Langley RG, Gudjonsson JE, Eidsmo L, Narbutt J, Czajkowski R, Pinter A, Pink AE, Rivera-Diaz R, Gianchandani DA, Kolbinger F, Bao W, Gaillez C, Jagiello P, Conrad C. Impact of early treatment of psoriasis on disease recurrence-Results from the STEPIn study. J Am Acad Dermatol. 2026 Jul;95(1):95-103. doi: 10.1016/j.jaad.2026.03.050. Epub 2026 Mar 23.
PubMed 41881197
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)
- ClinicalTrials.gov ID
- NCT03020199
- Acronym / sponsor ID
- STEPin / CAIN457A2322
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, interleukin (IL) 17A, IL-17A, secukinumab, AIN457, Narrow-band ultraviolet light B, nb-UVB, Psoriasis area and severity index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 1 Oct 2024
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 was to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).
Detailed description
This was and open label, parallel group, multicenter, randomized study with 3 clinical periods: Screening period, Treatment period, and Follow-up period.
The design consisted of the Main Study and a Mechanistic Sub study:
- The Main Study had 2-treatment-arm secukinumab and nb-UVB).
- The Mechanistic Sub-study had 4 arms treated with secukinumab and one arm with nb-UVB arm. The outcome measures were all exploratory, i.e. no results presented. Not all participants of the Mechanistic Sub-study participated in the Main Study, these participants are only reported for the safety analyses, but not for the primary and secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 300 mg | Experimental | Biological: SecukinumabIn the Main Study, 80 new-onset psoriasis patients in Arm A1 (68 in Arm A1a, 12 in Arm A1b) received 300 mg secukinumab injections weekly for the first month, then every 4 weeks until Week 48 (52-week treatment). Arm A1b patients also joined the Mechanistic Sub-study. In the Mechanistic Sub-study, 12 new-onset psoriasis patients (Arm A2) and 24 chronic plaque psoriasis patients (12 each in Arms C1 and C2) received similar secukinumab treatment. Arm A2 and C2 patients continued until Week 100 (104-week treatment), while Arm C1 ended at Week 48 (52-week treatment). |
| Narrow-band ultraviolet B (nb-UVB) | Active comparator | Radiation: nb-UVBIn the Main Study, 80 new-onset psoriasis patients in Arm B1 (68 in Arm B1a and 12 in Arm B1b) received 1 or 2 cycles of nb UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 did not receive a second treatment cycle) (treatment duration = 52 weeks). Patients from Arm B1b participated also in the Mechanistic Sub-study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed.
- Aged 18 to 50 years inclusive.
- New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arm A1, Arm A2, and Arm B1). Episodes of mild psoriasis, which occurred at least 3 years before screening and resolved spontaneously within 6 months will be accepted.
- Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2).
- Moderate to severe plaque psoriasis defined at screening and baseline by PASI >= 10, and body surface area (BSA) >= 10%, and IGA mod 2011 >= 3.
Key exclusion criteria (5 listed)
- Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced).
- Ongoing use of prohibited treatments.
- Previous treatment with phototherapy or any systemic treatment.
- Pregnant or nursing (lactating) women.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment period or longer if required by locally approved prescribing information (e.g., 20 weeks in the EU and countries where applicable for secukinumab).
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 |
|---|---|---|
| SecukinumabAlso: AIN457Secukinumab (AIN457) 300 mg was administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose was provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe was labeled as AIN457 150 mg/1 mL. | Biological | Secukinumab 300 mg |
| nb-UVBNarrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application was performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face was recommended | Radiation | Narrow-band ultraviolet B (nb-UVB) |
Primary outcome
Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52.
Time frame: Baseline, Week 52
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.
2 secondary outcomes
Number of Participants Who Achieved PASI 90 at Week 104
Time frame: Baseline, Week 104
Number of Participants With IGA Mod 2011 0/1 Response at Week 52
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42191094Gudjonsson JE, Bier K, Gaulis S, Tsoi LC, Cardner M, Sarkar MK, Coon A, Cole C, Karner J, Fernandez A, Peters T, Eidsmo L, Iversen L, Jagiello P, Ferrero E, Kolbinger F, Lohmann F, Conrad C. Early intervention with secukinumab prevents epigenetic scar development in new-onset psoriasis: STEPIn mechanistic substudy results. J Allergy Clin Immunol. 2026 May 25:S0091-6749(26)00367-2. doi: 10.1016/j.jaci.2026.04.028. Online ahead of print.
- Derived from this study: PubMed 41881197Iversen L, Langley RG, Gudjonsson JE, Eidsmo L, Narbutt J, Czajkowski R, Pinter A, Pink AE, Rivera-Diaz R, Gianchandani DA, Kolbinger F, Bao W, Gaillez C, Jagiello P, Conrad C. Impact of early treatment of psoriasis on disease recurrence-Results from the STEPIn study. J Am Acad Dermatol. 2026 Jul;95(1):95-103. doi: 10.1016/j.jaad.2026.03.050. Epub 2026 Mar 23.
- 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
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
44 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab and nb-UVB in people with Plaque Psoriasis, run by Novartis Pharmaceuticals at 44 sites in 13 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 5 inclusion and 5 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, Poland, Bulgaria, Germany, United Kingdom and 8 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 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 1 Oct 2024). 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?
Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (time frame: Baseline, Week 52). 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 NCT03020199, which also lists 2 linked publications.
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 28 Jan 2025.