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A prospective, single-center, single-arm study to evaluate the efficacy and safety of imetelstat in adults with severe alopecia areata refractory to systemic therapy.

A prospective, single-center, single-arm study to evaluate the efficacy and safety of imetelstat in adults with severe alopecia areata refractory to systemic therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117015
Enrollment
Unknown
Registered
2026-01-19
Start date
2026-01-24
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata, AA

Interventions

Trial group:Oral administration of imatinib at a dose of 4 mg once daily for 24 weeks, with completion of the 24-week efficacy and safety assessment.

Sponsors

Affiliated Hospital of Guilin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Be 18-65 years of age at the time of informed consent, regardless of gender; 2. Diagnosed with severe alopecia areata (SALT score >=50%, including alopecia totalis/universalis) with disease duration between 6 months and 8 years; 3. Prior inadequate response or intolerance to one systemic treatment (e.g., corticosteroids, immunosuppressants) for cumulative duration of more than 6 months; or inadequate response or intolerance to at least two systemic treatments, each lasting >=3 months; 4. In the investigator's opinion, planned to receive albociclib treatment; 5. Voluntarily provide informed consent prior to any study-related procedure, able to communicate effectively with the investigator, and willing and able to fully understand and strictly comply with the study protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Concomitant androgenetic alopecia or active scalp inflammation; alopecia areata in the recovery phase, excluding other causes of hair loss (e.g., androgenetic alopecia, scarring alopecia, chemotherapy-induced alopecia); 2. Active malignancy or recent history of malignancy; concomitant thrombosis or other autoimmune diseases; 3. Requiring long-term use of corticosteroids, non-steroidal anti-inflammatory drugs, systemic immunosuppressants, or biologic agents; 4. Severe hepatic or renal impairment, or peptic ulcer; 5. Hepatitis, tuberculosis, syphilis, HIV, herpes zoster, or other infectious diseases requiring systemic anti-infective treatment; 6. Having psychiatric or neurological disorders, history of substance abuse, poor compliance, or unwilling/unable to cooperate; 7. Pregnant or lactating women, or women of childbearing potential not using effective contraception; 8. Hypersensitivity to the active ingredient of albociclib or any excipient.

Design outcomes

Primary

MeasureTime frame
Alopecia Severity Scoring Tool;

Secondary

MeasureTime frame
Subject Global Assessment ;

Countries

China

Contacts

Public ContactYan Wenjie

Affiliated Hospital of Guilin Medical University

ywj716@qq.com+86 139 7831 1264

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026