Atopic DermatitisPhase 2Velarite-LTENCT07223697
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
A Phase 2 study testing Afimkibart in people with Atopic Dermatitis, run by Hoffmann-La Roche at 31 sites in 7 countries.
Trial summary
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 8 Jan 2026to 1 Mar 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study
- Parent Clinical Trial-Specific Criteria:
- Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved => EASI50 response from study baseline
Who cannot join
- Evidence of other skin conditions that would interfere with the assessment of AD
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
Brazil8 sites
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-686
Centro de Pesquisa São Lucas
Campinas, São Paulo, 13060-803
Centro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná, 80030-110
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital de Clnicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, 20241-180
HMCG - Hospital e Maternidade Dr. Christovo da Gama
Santo Andr, São Paulo, 09030-010
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
Sao Jose Rio Preto, São Paulo, 15090-000
United States7 sites
Hamilton Research, LLC
Alpharetta, Georgia, 30022
Best Skin Research LLC
Camp Hill, Pennsylvania, 17011
UCLA Division of Dermatology
Los Angeles, California, 90024
Dermatology Research Associate
Los Angeles, California, 90045
University of Minnesota
Minneapolis, Minnesota, 55455
Olympian Clinical Research
Tampa, Florida, 33615
Revival Research Institute, LLC
Troy, Michigan, 48084
Poland6 sites
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
Centrum Medyczne Pratia Katowice I
Katowice, Silesian Voivodeship, 40-081
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski s.c.
Krakow, 30-002
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, 31-011
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
Rzeszów, 35-055
Klinika Ambroziak Dermatologia
Warsaw, 02-953
Canada4 sites
DermEffects
London, Ontario, N6H 5L5
Lynderm Research Inc
Markham, Ontario, L3P 1X3
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Ryan Clinical Research Inc
Newmarket, Ontario, L3Y 5G8
Germany2 sites
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455
Dermatologikum Hamburg Gemeinschaftspraxis GbR
Hamburg, 20354
Italy2 sites
Azienda Ospedaliero Universitaria delle Marche
Ancona, The Marches, 60126
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Spain2 sites
Hospital Universitario Reina Sofia
Córdoba, 14004
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
About this study
Official title: An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
- Conditions
- Atopic Dermatitis
- Being tested
- Afimkibart
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called RO7790121, PF-06480605, RVT-3101
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart Group I | Experimental | Participants will receive Afimkibart as subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Afimkibart Group II | Experimental | Participants will receive Afimkibart as SC injection. Receives: Drug: Afimkibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: From Baseline up to 6 years
Secondary outcomes (11)
Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit
Measured: Baseline, Up to 6 years
Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit
Measured: Baseline, Up to 6 years
Percentage of Participants With EASI-50 at Each Visit
Measured: Up to 6 years
Percentage of Participants with EASI-75 at Each Visit
Measured: Up to 6 years
Percentage of Participants with EASI-90 at Each Visit
Measured: Up to 6 years
Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit
Measured: From Baseline up to 6 years
Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit
Measured: Baseline, Up to 6 years
Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit
Measured: Baseline, Up to 6 years
Serum Concentration of Afimkibart at Specified Timepoints
Measured: Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart
Measured: From Baseline up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Measured: From Baseline up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start8 Jan 2026
- Primary completion1 Mar 2033 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223697
- Sponsor's protocol ID
- CS45943
- Other IDs
- 2025-520771-59-00, 2025
- Acronym
- Velarite-LTE
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials
- ClinicalTrials.gov ID
- NCT07223697
- Acronym / sponsor ID
- Velarite-LTE / CS45943
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 1 Mar 2033 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afimkibart Group I | Experimental | Drug: AfimkibartParticipants will receive Afimkibart as subcutaneous (SC) injection. |
| Afimkibart Group II | Experimental | Drug: AfimkibartParticipants will receive Afimkibart as SC injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study
- Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved => EASI50 response from study baseline
Key exclusion criteria (4 listed)
- Evidence of other skin conditions that would interfere with the assessment of AD
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
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 |
|---|---|---|
| AfimkibartAlso: RO7790121, PF-06480605, RVT-3101Afimkibart SC injection will be administered as per the schedule defined in the protocol. | Drug | Afimkibart Group I, Afimkibart Group II |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: From Baseline up to 6 years
11 secondary outcomes
Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit
Time frame: Baseline, Up to 6 years
Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit
Time frame: Baseline, Up to 6 years
Percentage of Participants With EASI-50 at Each Visit
Time frame: Up to 6 years
Percentage of Participants with EASI-75 at Each Visit
Time frame: Up to 6 years
Percentage of Participants with EASI-90 at Each Visit
Time frame: Up to 6 years
Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit
Time frame: From Baseline up to 6 years
Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit
Time frame: Baseline, Up to 6 years
Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit
Time frame: Baseline, Up to 6 years
Serum Concentration of Afimkibart at Specified Timepoints
Time frame: Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart
Time frame: From Baseline up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Time frame: From Baseline up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
Clinical Trials study director
Hoffmann-La Roche
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afimkibart in people with Atopic Dermatitis, run by Hoffmann-La Roche at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Brazil, United States, Poland, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
This study is still under way. Results are not available in the source record yet.
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 Adverse Events (time frame: From Baseline up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.