Alopecia AreataPhase 2NCT06104839
Safety and Efficacy of Oral NXC-736 in Adult Participants With Moderate and Severe Alopecia Areata
A Phase 2 study testing NXC736 in people with Alopecia Areata, run by NEXTGEN Bioscience at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- NXC736
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Sep 2024to 31 Jan 2027
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between ≥19 and ≤65 years of age at the time of informed consent
- Moderate and severe alopecia areata as assessed by a SALT score of 25% ≤ SALT < 95% at Screening and Day 1/Baseline
- Current episode of hair loss for ≥6 months but <8 years
- Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Who cannot join
- Participants with the following medical history confirmed during screening:
- ohter Types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, androgenic alopecia, telogen effluvium, etc.)
- Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
- Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
YangHye Park contact
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital.
Seoul, 03080
Osang Kwon, 82-1800-1252, oskwon@snu.ac.kr
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Bark-Lynn Lew, 82-1800-1252, bellotte@hanmail.net
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Moderate and Severe Alopecia Areata
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).
- Conditions
- Alopecia Areata
- Being tested
- NXC736, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXC736Drug
oral administration
PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| NXC736 | Experimental | Not described Receives: Drug: NXC736 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change(%) in SALT score from baseline at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEXTGEN Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104839
- Sponsor's protocol ID
- NXC736-101
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Moderate and Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT06104839
- Acronym / sponsor ID
- NXC736-101
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- NEXTGEN BioscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Oct 2023 (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.
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (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
| Arm | Type | Receives |
|---|---|---|
| NXC736 | Experimental | Drug: NXC736 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women between ≥19 and ≤65 years of age at the time of informed consent
- Moderate and severe alopecia areata as assessed by a SALT score of 25% ≤ SALT < 95% at Screening and Day 1/Baseline
- Current episode of hair loss for ≥6 months but <8 years
- Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
- Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Key exclusion criteria (4 listed)
- Participants with the following medical history confirmed during screening:
- Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
- Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
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 |
|---|---|---|
| NXC736oral administration | Drug | NXC736 |
| Placebooral administration | Drug | Placebo |
Primary outcome
Change(%) in SALT score from baseline at Week 12
Time frame: 12 weeks
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 13 Apr 2026.
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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.
YangHye Park contact
2 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 NXC736 in people with Alopecia Areata, run by NEXTGEN Bioscience at 2 sites in South Korea.
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 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
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 Heesun Kim (82-31-606-3220, flower@nextgenbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change(%) in SALT score from baseline at Week 12 (time frame: 12 weeks). 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 13 Apr 2026.