Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.

NCT06278402 | Completed Phase 3 DMC

• 1 other identifier: JinnahH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2.

Conditions

Alopecia Areata; Alopecia Totalis; Alopecia Universalis

Keywords

Tofacitinib; Alopecia areata; Janus kinase inhibitor; JAK 1/3 inhibitor

Outcome Measures

Primary Outcomes (1)

• Alopecia

  To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth ≤10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥3.

  6 months

Study Arms (1)

Tofacitinib

EXPERIMENTAL

tofacitinib 5mg twice daily for 6 months

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Oral tofacitinib 5mg twice daily for treatment of alopecia areata, totalis and universalis.

Tofacitinib

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients presenting with Alopecia areata as per operational definition will be included in the study.
• Either gender.
• Age 15 - 60 years.

You may not qualify if:

• Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis.
• Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities.
• Patients positive for latent infections.
• Patients with weight \<25 kg.

Sponsors & Collaborators

• Jinnah Hospital: lead

Study Sites (1)

Misbah Zari Qadir

Karachi, Sindh, Pakistan

Location

Related Publications (10)

• Husein-ElAhmed H, Abdulla N, Al-Obaidli A, Ali-Alam M, Steinhoff M. Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. Dermatol Ther. 2022 Dec;35(12):e15871. doi: 10.1111/dth.15871. Epub 2022 Dec 1.

  PMID: 36177791 RESULT

• Sardana K, Bathula S, Khurana A. Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. Indian Dermatol Online J. 2023 Jun 28;14(4):465-474. doi: 10.4103/idoj.idoj_452_22. eCollection 2023 Jul-Aug.

  PMID: 37521227 RESULT

• Dillon KL. A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata. Clin Cosmet Investig Dermatol. 2021 Jun 25;14:691-714. doi: 10.2147/CCID.S309215. eCollection 2021.

  PMID: 34211288 RESULT

• Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.

  PMID: 28300084 RESULT

• Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7.

  PMID: 37339501 RESULT

• Gupta AK, Carviel JL, Foley KA, Shear NH, Piraccini BM, Piguet V, Tosti A. Monotherapy for Alopecia Areata: A Systematic Review and Network Meta-Analysis. Skin Appendage Disord. 2019 Nov;5(6):331-337. doi: 10.1159/000501940. Epub 2019 Aug 29.

  PMID: 31799258 RESULT

• Huang J, Deng S, Li J, Tang Y, Liu F, Liu Y, Rao S, Shi W. Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Acta Derm Venereol. 2023 Nov 13;103:adv13475. doi: 10.2340/actadv.v103.13475.

  PMID: 37955531 RESULT

• Damsky W, King BA. JAK inhibitors in dermatology: The promise of a new drug class. J Am Acad Dermatol. 2017 Apr;76(4):736-744. doi: 10.1016/j.jaad.2016.12.005. Epub 2017 Jan 28.

  PMID: 28139263 RESULT

• Craiglow BG, King BA. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J Invest Dermatol. 2014 Dec;134(12):2988-2990. doi: 10.1038/jid.2014.260. Epub 2014 Jun 18. No abstract available.

  PMID: 24940651 RESULT

• Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.

  PMID: 29273099 RESULT

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23.

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 26, 2024
• Study Start: July 1, 2023
• Primary Completion: January 6, 2024
• Study Completion: January 16, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)