Alopecia AreataPhase 2AZURENCT05205070
A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata
A Phase 2 study testing Rosnilimab in people with Alopecia Areata, run by AnaptysBio, Inc. at 16 sites in United States.
Trial summary
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Rosnilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 16 sitesUnited States
- Study dates
- 22 Dec 2021to 19 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
- Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is > 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).
Who cannot join
- Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
- Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
- Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Site 10-102
Bexley, Ohio, 43208
- Recruiting
10-105
Birmingham, Alabama, 35205
- Recruiting
Site 10-101
Charlotte, North Carolina, 28277
- Recruiting
Site 10-115
Chicago, Illinois, 60611
- Recruiting
Site 10-117
Clarkston, Michigan, 48346
- Recruiting
Site10-103
Encinitas, California, 92024
- Recruiting
10-110
Houston, Texas, 77056
- Recruiting
10-104
Indianapolis, Indiana, 46250
- Recruiting
Site 10-114
Kenosha, Wisconsin, 53144
- Recruiting
Site 10-116
Louisville, Kentucky, 40241
- Recruiting
Site 10-111
New York, New York, 10029
- Recruiting
Site 10-113
Northridge, California, 91324
- Recruiting
Site 10-109
Plainfield, Indiana, 46168
- Recruiting
Site 10-108
San Antonio, Texas, 78229
- Recruiting
Site 10-106
Tulsa, Oklahoma, 74136
- Recruiting
10-107
Upper Saint Clair, Pennsylvania, 15241
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects With Alopecia Areata
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata
Read the detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.
- Conditions
- Alopecia Areata
- Being tested
- Rosnilimab, Placebo
- Keywords
- PD-1 receptor, Rosnilimab
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosnilimabBiological
Also called ANB030
humanized monoclonal antibody
PlaceboBiological
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Rosnilimab (ANB030) | Experimental | ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks Receives: Biological: Rosnilimab |
| Placebo solution | Placebo comparator | Placebo solution, SC injections every 4 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start22 Dec 2021
- Primary completion19 Jan 2023 (estimated)
- Study completion19 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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
- Model description
- Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnaptysBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Randazzo, MD, Study director, AnaptysBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205070
- Sponsor's protocol ID
- ANB030-201
- Acronym
- AZURE
- Status last verified
- May 2022
- First submitted
- 11 Jan 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects With Alopecia Areata
- ClinicalTrials.gov ID
- NCT05205070
- Acronym / sponsor ID
- AZURE / ANB030-201
- Conditions
- Alopecia Areata
- Keywords
- PD-1 receptor, Rosnilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AnaptysBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 19 Mar 2023 (estimated)
- First posted
- 24 Jan 2022 (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.
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
| Arm | Type | Receives |
|---|---|---|
| Rosnilimab (ANB030) | Experimental | Biological: RosnilimabANB030 biological humanized monoclonal antibody, SC injections every 4 weeks |
| Placebo solution | Placebo comparator | Biological: PlaceboPlacebo solution, SC injections every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
- Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is > 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).
Key exclusion criteria (3 listed)
- Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
- Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
- Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).
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 |
|---|---|---|
| RosnilimabAlso: ANB030humanized monoclonal antibody | Biological | Rosnilimab (ANB030) |
| PlaceboPlacebo solution | Biological | Placebo solution |
Primary outcome
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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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.
Bruce Randazzo, MD study director
AnaptysBio, Inc.
16 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 Rosnilimab in people with Alopecia Areata, run by AnaptysBio, Inc. at 16 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AnaptysBio Inc. ((858)362-6295, clinicaltrialinfo@anaptysbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24 (time frame: Week 24). 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 10 May 2022.