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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002423-26 | EudraCT Number |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires | 1181 | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42191094 | Derived | 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. | |
| 41881197 |
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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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Subjects were enrolled in 2 study sites in Argentina, 4 in Bulgaria, 2 in Canada, 4 in Germany, 1 in Denmark, 3 in Estonia, 2 in Finland, 2 in Hungary, 6 in Poland, 8 in Spain, 2 in Sweden, 1 in Switzerland, and 4 in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 300 mg | Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks). |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2019 | Jun 13, 2024 |
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| nb-UVB | Radiation | 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 |
|
| 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. | Baseline, Week 52 |
| Buenos Aires |
| C1425DKG |
| Argentina |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Sofia | 1632 | Bulgaria |
| Novartis Investigative Site | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Novartis Investigative Site | Markham | Ontario | L3P 1X2 | Canada |
| Novartis Investigative Site | Aarhus N | 8200 | Denmark |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 50406 | Estonia |
| Novartis Investigative Site | Tampere | 33100 | Finland |
| Novartis Investigative Site | Turku | FIN-20100 | Finland |
| Novartis Investigative Site | Berlin | 10789 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | NyÃregyháza | 4400 | Hungary |
| Novartis Investigative Site | Szolnok | 5000 | Hungary |
| Novartis Investigative Site | Bialystok | 15-879 | Poland |
| Novartis Investigative Site | Bydgoszcz | 85-094 | Poland |
| Novartis Investigative Site | Gdansk | 80-803 | Poland |
| Novartis Investigative Site | Krakow | 31-070 | Poland |
| Novartis Investigative Site | Lodz | 90-436 | Poland |
| Novartis Investigative Site | Lodz | 90-647 | Poland |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Alcorcón | Madrid | 28922 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Las Palmas de Gran Canaria | 35010 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Madrid | 28031 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Gothenburg | 413 46 | Sweden |
| Novartis Investigative Site | Malmö | 214 28 | Sweden |
| Novartis Investigative Site | Lausanne | CH-1011 | Switzerland |
| Novartis Investigative Site | Bradford | West Yorkshire | BD5 0NA | United Kingdom |
| Novartis Investigative Site | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Salford | M6 8HD | United Kingdom |
| Derived |
| Iversen 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 Mar 23:S0190-9622(26)00459-7. doi: 10.1016/j.jaad.2026.03.050. Online ahead of print. |
| Narrow-band Ultraviolet B (Nb-UVB) |
Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks). |
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| Modified Full Analysis Set (mFAS) | All randomized subjects who received at least one dose of study treatment during the Treatment Period |
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| Subjects Not Treated |
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| Main Study |
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| Mechanistic Sub-study |
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| COMPLETED | Completed treatment |
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| NOT COMPLETED |
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| Follow-up Period |
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Subject disposition and baseline characteristics and presented using Randomized Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 300 mg | Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks). |
| BG001 | Narrow-band Ultraviolet B (Nb-UVB) | Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period | Posted | Count of Participants | Participants | Baseline, Week 52 |
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| Secondary | 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. | Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period | Posted | Count of Participants | Participants | Baseline, Week 104 |
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| Secondary | 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. | Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 52 |
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On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab 300 mg - On Treatment | AEs during on-treatment period (up to 84 days post-treatment) | 0 | 112 | 6 | 112 | 29 | 112 |
| EG001 | Narrow-band Ultraviolet B (Nb-UVB) - On Treatment | AEs during on-treatment period (up to 84 days post-treatment) | 0 | 76 | 1 | 76 | 8 | 76 |
| EG002 | Secukinumab 300 mg - Post Treatment Follow-up | AEs during follow-up period (starting from 85 days post-treatment) | 0 | 88 | 0 | 88 | 7 | 88 |
| EG003 | Narrow-band Ultraviolet B (Nb-UVB) - Post Treatment Follow-up | AEs during follow-up period (starting from 85 days post-treatment) | 0 | 76 | 1 | 76 | 2 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
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| Acute stress disorder | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | Jun 13, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| Study terminated by Sponsor |
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| Subject/guardian decision |
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| Male |
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| Asian |
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| American Indian or Alaska Native |
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| White |
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| Unknown |
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| Other |
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80 patients (68 in Arm B1a and 12 in Arm B1b) with new-onset psoriasis received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
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