PsoriasisPhase 3NCT03478787
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing risankizumab and secukinumab in people with Psoriasis, run by AbbVie at 61 sites in 9 countries.
Trial summary
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- risankizumab and secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 61 sitesin 9 countries
- Study dates
- 8 May 2018to 8 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
- Subject must be a candidate for systemic therapy as assessed by the investigator;
- Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Who cannot join
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
- History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
- Previous exposure to risankizumab
- Previous exposure to secukinumab
Trial locations and contacts
61 sites in 9 countries.
61 sites in 9 countries
United States28 sites
ORA, Inc. /ID# 204342
Andover, Massachusetts, 01810
Bakersfield Derma & Skin Cance /ID# 202115
Bakersfield, California, 93309
Beth Israel Deaconess Medical Center /ID# 204340
Boston, Massachusetts, 02215-5400
Synexus Research Cincinnati /ID# 202161
Cincinnati, Ohio, 45236
Psoriasis Treatment Ctr of Central NJ /ID# 202107
East Windsor, New Jersey, 08520
UConn Health Main /ID# 201745
Farmington, Connecticut, 06032
Center for Dermatology Clin Res /ID# 202116
Fremont, California, 94538
Advanced Research Associates - Glendale /ID# 204335
Glendale, Arizona, 85308
Center for Clinical Studies - Houston (Binz) /ID# 202178
Houston, Texas, 77004-8097
Clinical Partners, LLC /ID# 201736
Johnston, Rhode Island, 02919
Dermatology Res. Assoc., CA /ID# 202170
Los Angeles, California, 90045
Dermatology Specialists Resear /ID# 202145
Louisville, Kentucky, 40241
Froedtert Mem Lutheran Hosp /ID# 204896
Milwaukee, Wisconsin, 53226
Minnesota Clinical Study Center /ID# 202369
New Brighton, Minnesota, 55112
Tory P Sullivan, MD PA /ID# 202177
North Miami Beach, Florida, 33162-4708
Renstar Medical Research /ID# 202113
Ocala, Florida, 34470
Alliance Dermatology and MOHs /ID# 204336
Phoenix, Arizona, 85032
Progressive Medical Research /ID# 202183
Port Orange, Florida, 32127
Oregon Derm & Res. Ctr /ID# 201652
Portland, Oregon, 97210
Oregon Medical Res Center PC /ID# 201651
Portland, Oregon, 97223
Dermatology and Skin Cancer Specialists, LLC /ID# 203938
Rockville, Maryland, 20850
UC Davis Health /ID# 202263
Sacramento, California, 95816
University of Utah /ID# 204035
Salt Lake City, Utah, 84112-5500
Progressive Clinical Research /ID# 202155
San Antonio, Texas, 78229
Medderm Associates /ID# 202162
San Diego, California, 92103
Central Dermatology, PC /ID# 202156
St Louis, Missouri, 63117
Center for Clinical Studies - Webster TX /ID# 202154
Webster, Texas, 77598
Integrated Clinical Research LLC /ID# 202152
West Palm Beach, Florida, 33406-6063
Canada7 sites
Beacon Dermatology Inc /ID# 203054
Calgary, Alberta, T3E 0B2
Dr. Irina Turchin PC Inc. /ID# 203052
Fredericton, New Brunswick, E3B 1G9
Eastern Canada Cutaneous Resea /ID# 203045
Halifax, Nova Scotia, B3H 1Z2
Dermatrials Research /ID# 203051
Hamilton, Ontario, L8N 1Y2
Dermatologique du Quebec /ID# 203050
Québec, G1V 4X7
Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
Saint-Jérôme, Quebec, J7Z 7E2
Enverus Medical Research /ID# 203043
Surrey, British Columbia, V3V 0C6
Poland6 sites
Osteo-Medic S.C. /ID# 203742
Bialystok, Podlaskie Voivodeship, 15-351
Klinika Dermatologii Pod Fortem /ID# 204180
Krakow, Lesser Poland Voivodeship, 31-302
Dermed Centrum Medyczne Sp. z o.o /ID# 203171
Lodz, Łódź Voivodeship, 90-265
KSW nr1 w Rzeszowie /ID# 203776
Rzeszów, Podkarpackie Voivodeship, 35-055
Przychodnia Specjalistyczna High-Med /ID# 203183
Warsaw, Masovian Voivodeship, 01-817
Klinika Ambroziak Sp. z o.o. /ID# 203928
Warsaw, Masovian Voivodeship, 02-758
Spain6 sites
Hospital General Universitario Alicante /ID# 203764
Alicante, 03010
Hospital Universitario Clinico San Cecilio /ID# 203760
Granada, 18016
Hospital Universitario de la Princesa /ID# 203754
Madrid, 28006
Hospital Universitario 12 de Octubre /ID# 203756
Madrid, 28041
Hospital de Manises /ID# 203757
Manises, Valencia, 46940
Hospital Universitario Arnau Vilanova /ID# 203763
Valencia, 46015
France5 sites
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
Nice, 06202
Hopital Saint-Louis /ID# 203586
Paris, 75010
Polyclinique Courlancy /ID# 203588
Reims, 51100
Charles Nicolle CHU Rouen /ID# 203590
Rouen, Seine-Maritime, 76031
Hopital Larrey - CHU de Toulouse /ID# 203587
Toulouse, 31059
Netherlands3 sites
Academisch Medical center Amsterdam /ID# 202556
Amsterdam, North Holland, 1105 AZ
Bravis Ziekenhuis /ID# 205232
Bergen op Zoom, North Brabant, 4624 VT
Radboud Universitair Medisch Centrum /ID# 202560
Nijmegen, Gelderland, 6525 GA
United Kingdom3 sites
Whipps Cross Univ Hospital /ID# 204723
London, London, City of, E11 1NR
Guy's and St Thomas' NHS Found /ID# 204721
London, London, City of, SE1 9RT
The University of Manchester /ID# 204720
Salford, M6 8HD
Italy2 sites
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
Milan, Lombardy, 20122
Policlinico A. Gemelli /ID# 203009
Rome, Lazio, 00168
About this study
Official title: A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
- Conditions
- Psoriasis
- Being tested
- risankizumab, secukinumab
- Keywords
- Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risankizumabDrug
Also called ABBV-066, BI 655066, SKYRIZI
Subcutaneous (SC) injection
secukinumabDrug
Also called Cosentyx
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France). Receives: Drug: risankizumab |
| Secukinumab | Active comparator | Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. Receives: Drug: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Measured: Week 16
Percentage of Participants With a PASI 90 at Week 52
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Week 52
Secondary outcomes (3)
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Week 52
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5.
Measured: Week 52
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 May 2018
- Primary completion8 Jul 2020
- Study completion8 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 PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478787
- Sponsor's protocol ID
- M16-766
- Other IDs
- 2017-004932-12, 2017
- Status last verified
- Jun 2021
- First submitted
- 23 Mar 2018
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20.
PubMed 35050485
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
- ClinicalTrials.gov ID
- NCT03478787
- Acronym / sponsor ID
- M16-766
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: risankizumabParticipants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France). |
| Secukinumab | Active comparator | Drug: secukinumabParticipants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
- Subject must be a candidate for systemic therapy as assessed by the investigator;
- Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Key exclusion criteria (6 listed)
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
- History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
- Previous exposure to risankizumab
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 |
|---|---|---|
| risankizumabAlso: ABBV-066, BI 655066, SKYRIZISubcutaneous (SC) injection | Drug | Risankizumab |
| secukinumabAlso: CosentyxSubcutaneous (SC) injection | Drug | Secukinumab |
Primary outcome
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Time frame: Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Percentage of Participants With a PASI 90 at Week 52
Time frame: Week 52
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
3 secondary outcomes
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
Time frame: Week 52
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
Time frame: Week 52
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35050485Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
AbbVie Inc. study director
AbbVie
61 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risankizumab and secukinumab in people with Psoriasis, run by AbbVie at 61 sites in 9 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 4 inclusion and 6 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada, Poland, Spain, France and 4 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 13 Jul 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 Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 (time frame: Week 16). 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?
On the ClinicalTrials.gov record for NCT03478787, 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 13 Jul 2021.