Clinical trial · Interventional
Efalizumab in the Treatment of Alopecia, Phase II
Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II
NCT00746980CI-TRIAL-00022576withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Newly identified safety concerns have changed the risk and benefit considerations
Summary
Brief summary (as posted)
Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia Totalis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| efalizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Subjects receiving drug
- interventionNames
- Drug: efalizumab
Primary outcomes (1)
- measure
- Percentage re-growth of scalp hair loss
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Self-assessment (SA) and Static physician global assessment (SPGA)
- timeFrame
- 1 year
- measure
- Body hair re-growth at 48 weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study. * clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata. * 18-40 years of age. * if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. * if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. Exclusion Criteria: * known hypersensitivity to efalizumab (Raptiva) or any of its components. * known liver disease, including active hepatitis * history of autoimmune diseases causing alopecia other than alopecia areata. * prior biologic therapy within 6 months prior to study initiation. * history of any malignancy within last ten years, except treated non-melanoma skin cancers. * any woman currently pregnant or lactating. * intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation. * history of positive PPD and/or tuberculosis. * history of HIV/AIDS * prior enrollment in any efalizumab study * any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * participation in another simultaneous clinical trial involving investigational agents. * positive HIV screening test obtained at screening visit. * positive QuantiFERON-TB test obtained at screening visit. * positive hepatitis screen obtained at screening visit. * platelet count 150 x 10(9)/L at baseline visit. * presence of any abnormal laboratory value obtained at screening visit assessed as clinically significant by principal investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.