Atopic DermatitisPhase 2NCT01986933

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

A Phase 2 study testing nemolizumab (CIM331) in people with Atopic Dermatitis, run by Chugai Pharmaceutical at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: nemolizumab (CIM331)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 264 participants
Where: 18 sitesUnited States
Study dates: Nov 2013to Jun 2016
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 and ≤65 years of age at the time of consent.
Patients with Atopic Dermatitis
Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Who cannot join

Serological evidence of hepatitis B virus or hepatitis C virus infection
Known human immunodeficiency virus infection
Ongoing treatment with specific or non-specific hyposensitization therapy for AD
Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
Pregnant or lactating women.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Study site
Alpharetta, Georgia, 30022
Study site
Anniston, Alabama, 36207
Study site
Arlington Heights, Illinois, 60005
Study site
Bay City, Michigan, 48706
Study site
Charleston, South Carolina, 29407
Study site
Charleston, South Carolina, 29425
Study site
Charlotte, North Carolina, 28226
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44106
Study site
College Station, Texas, 77845
Study site
Indianapolis, Indiana, 46256
Study site
Louisville, Kentucky, 40202
Study site
Louisville, Kentucky, 40217
Study site
Miami, Florida, 33142
Study site
New York, New York, 10016
Study site
Norfolk, Virginia, 23507
Study site
Portland, Oregon, 97239
Study site
San Diego, California, 92122

Other trials in United States

About this study

Official title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Conditions: Atopic Dermatitis
Being tested: nemolizumab (CIM331), Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nemolizumab (CIM331)Drug
PlaceboOther

Study groups in NCT01986933
Study group	Role	What they receive
Group1	Experimental	Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) Receives: Drug: nemolizumab (CIM331)
Group2	Experimental	Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) Receives: Drug: nemolizumab (CIM331)
Group3	Experimental	Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) Receives: Drug: nemolizumab (CIM331)
Group4	Experimental	Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) Receives: Drug: nemolizumab (CIM331)
Group5	Experimental	Part A: Placebo Part B: nemolizumab (CIM331) Receives: Drug: nemolizumab (CIM331); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).
When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12

Secondary outcomes (8)

Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).
When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A)
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).
When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]).
When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]).
When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.
When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.
When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Measured: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.
When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Measured: baseline to Week 12 (Part A)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.
When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Measured: baseline to Week 12 (Part A), up to Week 64 (Part B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Jun 2016

First posted19 Nov 2013 (estimated)
Study startNov 2013
Primary completionApr 2015
Study completionJun 2016

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 Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986933
Sponsor's protocol ID: CIM003JG
Status last verified: Jan 2022
First submitted: 31 Oct 2013
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.
PubMed 29753033
Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.
PubMed 28249150

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY
ClinicalTrials.gov ID: NCT01986933
Acronym / sponsor ID: CIM003JG
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: Chugai PharmaceuticalIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Apr 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 22 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group1	Experimental	Drug: nemolizumab (CIM331)Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Group2	Experimental	Drug: nemolizumab (CIM331)Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Group3	Experimental	Drug: nemolizumab (CIM331)Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Group4	Experimental	Drug: nemolizumab (CIM331)Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Group5	Experimental	Drug: nemolizumab (CIM331), Other: PlaceboPart A: Placebo Part B: nemolizumab (CIM331)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 and ≤65 years of age at the time of consent.
Patients with Atopic Dermatitis
Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Key exclusion criteria (7 listed)

Serological evidence of hepatitis B virus or hepatitis C virus infection
Known human immunodeficiency virus infection
Ongoing treatment with specific or non-specific hyposensitization therapy for AD
Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.

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
nemolizumab (CIM331)	Drug	Group1, Group2, Group3, Group4, Group5
Placebo	Other	Group5

Primary outcome

Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
Time frame: baseline to Week 12
Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).

8 secondary outcomes

Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
Time frame: baseline to Week 12 (Part A)
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
Time frame: baseline to Week 12 (Part A)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
Time frame: baseline to Week 12 (Part A)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
Time frame: baseline to Week 12 (Part A)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)

Results and safety

Results posted to the registry on 22 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	53	44
Nemoliozumab (0.1 mg/kg) Q4W	53	44
Nemoliozumab (0.5 mg/kg) Q4W	54	45
Nemoliozumab (2.0 mg/kg) Q4W	52	45
Nemoliozumab (2.0 mg/kg) Q8W	52	38

Primary outcome: Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12

Time frame: baseline to Week 12. Least squares mean (95% Confidence Interval). Unit: percentage change

Measure	Placebo (Part A) n = 43	Nemoliozumab (0.1 mg/kg) Q4W (Part A) n = 44	Nemoliozumab (0.5 mg/kg) Q4W (Part A) n = 43	Nemoliozumab (2.0 mg/kg) Q4W (Part A) n = 46
Value	-20.07 (-29.94 to -10.21)	-41.46 (-51.21 to -31.71)	-61.24 (-71.13 to -51.35)	-60.46 (-69.98 to -50.95)

Placebo (Part A) vs Nemoliozumab (0.1 mg/kg) Q4W (Part A): Mean Difference (Final Values): -21.39 (95% CI -35.25 to -7.53), p = 0.0027, ANCOVA
Placebo (Part A) vs Nemoliozumab (0.5 mg/kg) Q4W (Part A): Mean Difference (Final Values): -41.16 (95% CI -55.17 to -27.15), p <0.0001, ANCOVA
Placebo (Part A) vs Nemoliozumab (2.0 mg/kg) Q4W (Part A): Mean Difference (Final Values): -40.39 (95% CI -54.11 to -26.67), p <0.0001, ANCOVA

Population analysed: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A)	1 of 53 (1.9%)	27 of 53 (50.9%)	0 of 53
Nemoliozumab (0.1 mg/kg) Q4W (Part A)	1 of 53 (1.9%)	29 of 53 (54.7%)	0 of 53
Nemoliozumab (0.5 mg/kg) Q4W (Part A)	0 of 54 (0%)	23 of 54 (42.6%)	0 of 54
Nemoliozumab (2.0 mg/kg) Q4W (Part A)	3 of 52 (5.8%)	27 of 52 (51.9%)	0 of 52
Nemoliozumab (2.0 mg/kg) Q8W (Part A)	5 of 52 (9.6%)	25 of 52 (48.1%)	0 of 52
Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)	3 of 53 (5.7%)	37 of 53 (69.8%)	0 of 53
Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)	3 of 54 (5.6%)	35 of 54 (64.8%)	0 of 54
Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)	4 of 52 (7.7%)	33 of 52 (63.5%)	0 of 52
Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)	9 of 52 (17.3%)	35 of 52 (67.3%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29753033Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.
Derived from this study: PubMed 28249150Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.

Related trials for Atopic Dermatitis

RecruitingPhase 2
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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.

Ryosuke Mihara study director

Chugai Pharmaceutical

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nemolizumab (CIM331) in people with Atopic Dermatitis, run by Chugai Pharmaceutical at 18 sites in United States.

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 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Nov 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?

Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 (time frame: baseline to Week 12). 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 NCT01986933, 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 25 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.