Clinical Trials
3
Active:1
Completed:1
Trial Phases
2 Phases
Phase 1:2
Phase 2:1
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (3 trials with phase data)• Click on a phase to view related trials
Phase 1
2 (66.7%)Phase 2
1 (33.3%)A Phase 2 Study of TCP-25 Gel in Patients with Epidermolysis Bullosa, STEP-study
Phase 2
Not yet recruiting
- Conditions
- Epidermolysis Bullosa (EB)
- Interventions
- Drug: Vehicle (placebo)
- First Posted Date
- 2024-09-13
- Last Posted Date
- 2024-09-13
- Lead Sponsor
- Xinnate AB
- Target Recruit Count
- 26
- Registration Number
- NCT06594393
- Locations
- 🇸🇪
University hospital, Lund, Skane, Sweden
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
Phase 1
Completed
- Conditions
- BlisterWound of SkinEpidermolysis BullosaVaricose Ulcer of Lower Limb
- Interventions
- Drug: TCP-25 gel 2.9 mg/ml or placebo gelDrug: TCP-25 gel 0.86 mg/ml or placebo gelDrug: TCP-25 gel 8.6 mg/ml or placebo gel
- First Posted Date
- 2022-05-18
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- Xinnate AB
- Target Recruit Count
- 35
- Registration Number
- NCT05378997
- Locations
- 🇸🇪
Skåne University Hospital in Lund, Clinical Trial Unit, Lund, Sweden
News
FDA Upgrades Xinnate's TCP-25 Trial for Epidermolysis Bullosa to Registrational Status
Following a successful Type C meeting with the FDA, Xinnate's upcoming STEP trial for TCP-25 in Epidermolysis Bullosa patients has been upgraded to serve as a registrational trial.