AlopeciaPhase 2NCT02781311
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
A Phase 2 study testing Setipiprant and Finasteride in people with Alopecia, run by Allergan at 18 sites in United States.
Trial summary
This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Alopecia
- What is being tested?
- Setipiprant and Finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 18 sitesUnited States
- Study dates
- 14 Jul 2016to 22 May 2018
- 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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Participant has androgenetic alopecia (AGA)
- Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.
Who cannot join
- History of hair loss for reasons other than AGA
- Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
- Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
- Hair-weaving within 6 months
- Use of hair colorants or dyes within 6 months.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
DermResearch, Inc
Austin, Texas, 78759
DeNova Research
Chicago, Illinois, 60611
Cleveland Clinic, Dept of Dermatology
Cleveland, Ohio, 44195
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Radiant Research, Inc.
Greer, South Carolina, 29650
Penn State Hershey Medical Center Dermatology Research Office
Hershey, Pennsylvania, 17033
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzzane Bruce and Associates P.A., The Center for Skin Research
Katy, Texas, 77494
Petrus Center for Aesthetic Surgery & Hair Transplantation
Little Rock, Arkansas, 72205
The Education & Research Foundation, Inc
Lynchburg, Virginia, 24501
University of Minnesota Department of Dermatology Division of Clinical research
Minneapolis, Minnesota, 55455
NW Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
Therapeutics Clinical Research
San Diego, California, 92123
Radiant Research, Inc.
Santa Rosa, California, 95405
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
Winston-Salem, North Carolina, 27157
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).
- Conditions
- Alopecia
- Being tested
- Setipiprant, Placebo, Finasteride
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetipiprantDrug
Also called KYTH-105, AGN-241679
Setipiprant tablets, orally, BID for 24 weeks.
PlaceboDrug
Placebo tablets, orally, BID for 24 weeks.
FinasterideDrug
Finasteride tablet, orally, once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Setipiprant | Experimental | Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. Receives: Drug: Setipiprant |
| Placebo | Placebo comparator | Two placebo tablets BID at 12-hour intervals for 24 weeks. Receives: Drug: Placebo |
| Finasteride | Active comparator | Finasteride 1 mg tablet, orally, once daily for 24 weeks. Receives: Drug: Finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Target Area Hair Count (TAHC) at Week 24
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.
Measured: Baseline (Day 1) to Week 24
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.
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 May 2016 (estimated)
- Study start14 Jul 2016
- Primary completion15 Mar 2018
- Study completion22 May 2018
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.
- Other trials for AlopeciaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joan-En Lin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781311
- Sponsor's protocol ID
- 1922-201-002
- Status last verified
- Mar 2019
- First submitted
- 20 May 2016
- Last updated
- 5 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
- ClinicalTrials.gov ID
- NCT02781311
- Acronym / sponsor ID
- 1922-201-002
- Conditions
- Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 5 Apr 2019
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 evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Setipiprant | Experimental | Drug: SetipiprantSetipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo tablets BID at 12-hour intervals for 24 weeks. |
| Finasteride | Active comparator | Drug: FinasterideFinasteride 1 mg tablet, orally, once daily for 24 weeks. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participant has androgenetic alopecia (AGA)
- Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.
Key exclusion criteria (5 listed)
- History of hair loss for reasons other than AGA
- Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
- Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
- Hair-weaving within 6 months
- Use of hair colorants or dyes within 6 months.
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 |
|---|---|---|
| SetipiprantAlso: KYTH-105, AGN-241679Setipiprant tablets, orally, BID for 24 weeks. | Drug | Setipiprant |
| PlaceboPlacebo tablets, orally, BID for 24 weeks. | Drug | Placebo |
| FinasterideFinasteride tablet, orally, once daily for 24 weeks. | Drug | Finasteride |
Primary outcome
Change From Baseline in Target Area Hair Count (TAHC) at Week 24
Time frame: Baseline (Day 1) to Week 24
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
Time frame: Week 24
The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joan-En Lin study director
Allergan
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 Setipiprant and Finasteride in people with Alopecia, run by Allergan 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 2 inclusion and 5 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 Apr 2019. 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. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2019). 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?
Change From Baseline in Target Area Hair Count (TAHC) at Week 24 (time frame: Baseline (Day 1) to Week 24). The study lists 2 primary outcomes in all. 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 Apr 2019.