Atopic DermatitisPhase 1NCT06673654
A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.
A Phase 1 study testing Ruxolitinib Topical Cream 1.5% and OPZELURA (Ruxolitinib) Cream in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ruxolitinib Topical Cream 1.5% and OPZELURA (Ruxolitinib) Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 23 Sep 2024
- Phase
- Phase 1
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥ 12 years
- Subjects who are 18 years of age or older must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- Subjects who have a clinical diagnosis of AD as defined by the criteria of Hanifin and Rajka.
- Subjects who have a clinical diagnosis of AD for at least 2 years.
- Subjects who have IGA Score of 2 (Mild) or 3 (Moderate) for AD severity.
- Subjects who have AD involvement of 3-20% of the body surface area (BSA) and does not include the scalp.
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
- Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of AD (e.g., other types of eczema, pigmentation, or extensive scarring).
Trial locations and contacts
1 site in 1 country.
United States1 site
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and Both Active Treatments to a Placebo Control in the Treatment of Mild-to-Moderate Atopic Dermatitis.
To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis
Read the detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Ruxolitinib Topical Cream 1.5%, OPZELURA (Ruxolitinib) Cream, 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.
Ruxolitinib Topical Cream 1.5%Drug
Also called Test Product
The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
OPZELURA (Ruxolitinib) CreamDrug
Also called Reference Product
The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
PlaceboDrug
Also called Vehicle
The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib Topical Cream 1.5% | Experimental | The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. Receives: Drug: Ruxolitinib Topical Cream 1.5% |
| OPZELURA (Ruxolitinib) Cream | Active comparator | The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. Receives: Drug: OPZELURA (Ruxolitinib) Cream |
| Placebo Control | Placebo comparator | The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products.
The percentage of subjects in each treatment group with "Treatment Success" (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at the Week 8 (Day 56 ± 4 days) visit.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start11 Aug 2023
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy Silverman, Study chair, Catawba Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673654
- Sponsor's protocol ID
- RXLC-2118
- Status last verified
- Oct 2023
- First submitted
- 2 Nov 2024
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and Both Active Treatments to a Placebo Control in the Treatment of Mild-to-Moderate Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT06673654
- Acronym / sponsor ID
- RXLC-2118
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 5 Nov 2024 (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.
To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis
Detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib Topical Cream 1.5% | Experimental | Drug: Ruxolitinib Topical Cream 1.5%The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. |
| OPZELURA (Ruxolitinib) Cream | Active comparator | Drug: OPZELURA (Ruxolitinib) CreamThe investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. |
| Placebo Control | Placebo comparator | Drug: PlaceboThe investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or non-pregnant female aged ≥ 12 years
- Subjects who are 18 years of age or older must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
- Subjects who have a clinical diagnosis of AD as defined by the criteria of Hanifin and Rajka.
- Subjects who have a clinical diagnosis of AD for at least 2 years.
- Subjects who have IGA Score of 2 (Mild) or 3 (Moderate) for AD severity.
Key exclusion criteria (4 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
- Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of AD (e.g., other types of eczema, pigmentation, or extensive scarring).
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 |
|---|---|---|
| Ruxolitinib Topical Cream 1.5%Also: Test ProductThe investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. | Drug | Ruxolitinib Topical Cream 1.5% |
| OPZELURA (Ruxolitinib) CreamAlso: Reference ProductThe investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. | Drug | OPZELURA (Ruxolitinib) Cream |
| PlaceboAlso: VehicleThe investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g. | Drug | Placebo Control |
Primary outcome
Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products.
Time frame: Baseline to Week 8
The percentage of subjects in each treatment group with "Treatment Success" (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at the Week 8 (Day 56 ± 4 days) visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Andy Silverman study chair
Catawba Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib Topical Cream 1.5% and OPZELURA (Ruxolitinib) Cream in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries, Inc. at 1 site 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 6 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products. (time frame: Baseline to Week 8). 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 5 Nov 2024.