Atopic KeratoconjunctivitisPhase 3NCT07395232
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
A Phase 3 study testing DFL24498 and dexamethasone sodium phosphate (DSP) ophthalmic solution in people with Atopic Keratoconjunctivitis, run by Dompé Farmaceutici S.p.A at 19 sites in 3 countries.
Trial summary
This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Atopic Keratoconjunctivitis
- What is being tested?
- DFL24498 and dexamethasone sodium phosphate (DSP) ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 1 Dec 2025to May 2027
- Phase
- Phase 3
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or Female aged ≥ 10 and ≤ 65 years.
- Diagnosis of AKC in both eyes, including the presence or medical history of the following:
- other atopic condition (ie., atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
- chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
- Ocular itching of at least 50 as assessed by VAS scale.
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- Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
- A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method.
Who cannot join
- Participants will be excluded if any of the following criteria apply:
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
- Evidence of an active ocular infection in either eye.
- Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
- Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.
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- Participants that are anatomically monocular.
- Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study.
- Note: Additional protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) contact
19 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
Duke Eye Center - Ophthalmology
Durham, North Carolina, 27710
- Recruiting
Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology
Houston, Texas, 77030
- Recruiting
Bowden Eye Associates - Southside Location
Jacksonville, Florida, 32256
- Recruiting
Total Eye Care, PA
Memphis, Tennessee, 38119
- Recruiting
University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida, 33136
- Recruiting
Clayton Eye Clinical Research
Morrow, Georgia, 30260
- Recruiting
NYU Langone Health - Eye Center
New York, New York, 10017
- Recruiting
Ophthalmology Associates
St Louis, Missouri, 63131
Italy6 sites, 6 recruiting
- Recruiting
IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
Bologna, 40138
- Recruiting
Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
Chieti, 66100
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
- Recruiting
AOU Policlinico Umberto I
Roma, 00161
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134
Spain5 sites, 5 recruiting
- Recruiting
METAVISION ARRUZAFA S.L. (Hospital Arruzafa)
Córdoba, 14012
- Recruiting
Miranza Galicia
Santiago de Compostela, 15706
- Recruiting
Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)
Valencia, 46015
- Recruiting
OBA - Universidad de Valladolid
Valladolid, 47011
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Participants With Atopic Keratoconjunctivitis (AKC)
This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.
Read the detailed description
The study will consist of 3 periods:
- Washout period (from Day -7 ± 1 to Day 1),
- Treatment Period (from randomization through Week12) and
- Follow-up period (Weeks 13 to 16).
- Conditions
- Atopic Keratoconjunctivitis
- Being tested
- DFL24498, Vehicle, dexamethasone sodium phosphate (DSP) ophthalmic solution
- Keywords
- chronic, recurrent ocular surface inflammation,, Atopic Keratoconjunctivitis, DFL24498, Ophthalmic solution, Vehicle controlled, Eye drop solution, Corneal involvement
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFL24498Drug
DFL24498 will be instilled in each eye for 12 Weeks.
VehicleDrug
Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
dexamethasone sodium phosphate (DSP) ophthalmic solutionDrug
Rescue medication may be administered as required at the Investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| DFL24498 | Experimental | Participants will be administered with DFL24498 eye drops in both eyes. Receives: Drug: DFL24498; Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution |
| Vehicle | Placebo comparator | Participants will be administered with vehicle eye drops in both eyes. Receives: Drug: Vehicle; Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Measured: Baseline and at Week 6
Secondary outcomes (16)
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Examination will be performed at the slit-lamp using blue (cobalt) light. Corneal fluorescein staining will be graded according to the modified Oxford scale (7-point scale: 0, 0.5. 1, 2, 3, 4, 5).
Measured: Baseline and at Week 6
Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.
Bulbar conjunctival redness will be assessed at the slit-lamp examination using white light prior to vital dye instillation and graded according to the VBR 10 scale.
Measured: Baseline and at Week 6
Change from baseline over time in ocular itching score assessed by VAS.
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).
Ocular symptoms are assessed using a 4-point severity scale ranging from 0 (none) to 3 (severe). Five ocular symptoms, itching, tearing, ocular discomfort (including burning, stinging, and foreign body sensation), mucous discharge, and photophobia are evaluated in the study eye. A composite symptom score is described in calculated at screening and Baseline by summing the individual symptom scores, resulting in a total score range of 0 to 15, with higher scores indicating greater symptom severity.
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in corneal fluorescein staining (modified Oxford scale) in the study eye.
Corneal fluorescein staining modified Oxford scale (0-5) as per corneal dot count in each eye.
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in bulbar conjunctival hyperemia assessed by VBR 10 scale (0 to 100) in the study eye.
Bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100).
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in signs of tarsal papillary reaction, corneal neovascularization, cicatrizing conjunctivitis and blepharitis on a 4-point scale (0 to 3) in the study eye.
Change in signs on a 4-point scale (0 to 3) in the study eye.
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 6 and 12 in the QoL scores assessed by the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ-S) (assessed in the adult cohort only)
Standardized Rhinoconjunctivitis QoL Questionnaire (RQLQ[S]) is a validated questionnaire that assesses QoL specifically in patients with rhinoconjunctivitis. There are 28 questions, which are categorized under 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Each question is scored on a 7-point scale from no impairment (score 0) to severe impairment (score 6).
Measured: Baseline and at Week 6 and Week 12.
Patient Global Impression of Change (PGIC) at week 6 and week 12 (assessed in the adult cohort only)
PGIC is a short questionnaire used to assess how a participant perceives changes in their condition following treatment, on a scale ranging from 1 to 7.
Measured: At week 6 and week 12.
Number of Participants receiving rescue medication over time after week 6
Participants who received rescued medication over time after week 6 (visit 4).
Measured: Week 6 to Week 12
Number of participants with treatment-emergent adverse events and serious adverse events (SAEs)
Any adverse events occurring or worsening after the first administration of investigational product is classified as "treatment-emergent" adverse events and does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Measured: Up to Week 16
Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye.
Best corrected visual acuity (BCDVA) is determined by careful refraction according to the standard protocol for refraction. BCDVA is measured by Early Treatment of Diabetic Retinopathy Study chart.
Measured: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 12 in corneal endothelial cell density in each eye (only at selected sites that have the required equipment).
Corneal central region endothelial cell density will be determined for each eye using specular microscopy and expressed as the number of cells/mm2 using the Cell Density readout provided by the software.
Measured: Baseline and at week 12
Change from baseline at week 12 in dilated fundus exam in each eye
After specular microscopy, mydriatic drops will be instilled in both eyes and once adequate dilation is achieved, a fundal exam shall be performed to examine the vitreous, retina, and optic nerve.
Measured: Baseline and at week 12
Change from baseline over time in intraocular pressure in each eye.
IOP will be assessed by tonometry for each eye and will be measured in mmHg.
Measured: Baseline and at Week 6 and Week 12
Number of participants discontinued due to tolerability during the treatment period
Treatment discontinuation rate due to tolerability.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic KeratoconjunctivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395232
- Sponsor's protocol ID
- ICY-AKC-301
- Other IDs
- 2025-522291-83-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2025
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Participants With Atopic Keratoconjunctivitis (AKC)
- ClinicalTrials.gov ID
- NCT07395232
- Acronym / sponsor ID
- ICY-AKC-301
- Conditions
- Atopic Keratoconjunctivitis
- Keywords
- chronic, recurrent ocular surface inflammation,, Atopic Keratoconjunctivitis, DFL24498, Ophthalmic solution, Vehicle controlled, Eye drop solution, Corneal involvement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Feb 2026 (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 is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.
Detailed description
The study will consist of 3 periods:
- Washout period (from Day -7 ± 1 to Day 1),
- Treatment Period (from randomization through Week12) and
- Follow-up period (Weeks 13 to 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFL24498 | Experimental | Drug: DFL24498, Drug: dexamethasone sodium phosphate (DSP) ophthalmic solutionParticipants will be administered with DFL24498 eye drops in both eyes. |
| Vehicle | Placebo comparator | Drug: Vehicle, Drug: dexamethasone sodium phosphate (DSP) ophthalmic solutionParticipants will be administered with vehicle eye drops in both eyes. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or Female aged ≥ 10 and ≤ 65 years.
- Diagnosis of AKC in both eyes, including the presence or medical history of the following:
- Ocular itching of at least 50 as assessed by VAS scale.
- Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
Key exclusion criteria (9 listed)
- Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
- Evidence of an active ocular infection in either eye.
- Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
- Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.
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 |
|---|---|---|
| DFL24498DFL24498 will be instilled in each eye for 12 Weeks. | Drug | DFL24498 |
| VehicleVehicle eye drops without active drug will be instilled in each eye for 12 Weeks. | Drug | Vehicle |
| dexamethasone sodium phosphate (DSP) ophthalmic solutionRescue medication may be administered as required at the Investigator discretion. | Drug | DFL24498, Vehicle |
Primary outcome
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
Time frame: Baseline and at Week 6
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
16 secondary outcomes
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.
Time frame: Baseline and at Week 6
Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.
Time frame: Baseline and at Week 6
Change from baseline over time in ocular itching score assessed by VAS.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in corneal fluorescein staining (modified Oxford scale) in the study eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in bulbar conjunctival hyperemia assessed by VBR 10 scale (0 to 100) in the study eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in signs of tarsal papillary reaction, corneal neovascularization, cicatrizing conjunctivitis and blepharitis on a 4-point scale (0 to 3) in the study eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 6 and 12 in the QoL scores assessed by the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ-S) (assessed in the adult cohort only)
Time frame: Baseline and at Week 6 and Week 12.
Patient Global Impression of Change (PGIC) at week 6 and week 12 (assessed in the adult cohort only)
Time frame: At week 6 and week 12.
Number of Participants receiving rescue medication over time after week 6
Time frame: Week 6 to Week 12
Number of participants with treatment-emergent adverse events and serious adverse events (SAEs)
Time frame: Up to Week 16
Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye.
Time frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 12 in corneal endothelial cell density in each eye (only at selected sites that have the required equipment).
Time frame: Baseline and at week 12
Change from baseline at week 12 in dilated fundus exam in each eye
Time frame: Baseline and at week 12
Change from baseline over time in intraocular pressure in each eye.
Time frame: Baseline and at Week 6 and Week 12
Number of participants discontinued due to tolerability during the treatment period
Time frame: Baseline to week 12
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 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Atopic Keratoconjunctivitis
Active, not recruitingObservational study
Ocular Comorbidity in Atopic Dermatitis
Atopic Keratoconjunctivitis
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.
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) contact
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DFL24498 and dexamethasone sodium phosphate (DSP) ophthalmic solution in people with Atopic Keratoconjunctivitis, run by Dompé Farmaceutici S.p.A at 19 sites in 3 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Italy, Spain. 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 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?
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?
Contact Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) (+39 02 583 831), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). (time frame: Baseline and at Week 6). 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 21 Sep 2026.