Clinical trials: sponsored by Krystal Biotech, Inc.
Hailey Hailey Disease, Skin Diseases
A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease
An open-label study to evaluate the safety and efficacy of KB111 in pediatric and adult subjects with Hailey-Hailey Disease
- Conditions
- Hailey Hailey Disease, Skin Diseases, Lesion Skin
- Trial name
- HALITE-1 (NCT07717346)
- Testing
- KB111
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Krystal Biotech, Inc.
Cystic Fibrosis
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
- Trial name
- NCT05504837
- Testing
- KB407 (Nebulization)
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to…
- Conditions
- Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
- Trial name
- IOLITE (NCT07016750)
- Testing
- KB803
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Krystal Biotech, Inc.
Neurotrophic Keratitis
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people…
- Trial name
- EMERALD-1 (NCT06999733)
- Testing
- KB801
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Krystal Biotech, Inc.
Lung Cancer, Non-small Cell, Lung Cancer Metastatic
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local…
- Conditions
- Lung Cancer, Non-small Cell, Lung Cancer Metastatic, Solid Tumor, Adult, Advanced Cancer
- Trial name
- KYANITE-1 (NCT06228326)
- Testing
- KB707, Pembrolizumab (KEYTRUDA®), Chemotherapy
- Where
- 14 sites in United States
- Volunteers
- 250 people
- Sponsor
- Krystal Biotech, Inc.
Alpha 1-Antitrypsin Deficiency
A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
The Sponsor is developing KB408, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human SERPINA1 to the airways of people with alpha-1…
- Trial name
- Serpentine-1 (NCT06049082)
- Testing
- KB408 (Nebulization)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Krystal Biotech, Inc.
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).
- Conditions
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive, Epidermolysis Bullosa Dystrophica Dominans
- Trial name
- NCT06563414
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Krystal Biotech, Inc.
Cancer, Melanoma Stage III
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on…
- Conditions
- Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma
- Trial name
- NCT05970497
- Testing
- KB707, Opdualag, KEYTRUDA ®( Pembrolizumab)
- Where
- 15 sites in United States
- Volunteers
- 240 people
- Sponsor
- Krystal Biotech, Inc.
Wrinkles in Decolletage, Pigmentation
A Study Assessing KB304 for the Treatment of Wrinkles in Women
The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area).
- Conditions
- Wrinkles in Decolletage, Pigmentation, Décolleté Wrinkles
- Trial name
- Pearl-2 (NCT06724900)
- Testing
- KB304, 0.9% Normal Saline (NS)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Krystal Biotech, Inc.
Skin Roughness, Wrinkle
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
- Conditions
- Skin Roughness, Wrinkle, Fine Lines, Skin Thickness
- Trial name
- NCT04540900
- Testing
- KB301
- Where
- 4 sites in United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa
This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB).
- Conditions
- Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
- Trial name
- NCT04917874
- Testing
- Open Label Topical Beremagene Geperpavec (B-VEC)
- Where
- 6 sites in United States
- Volunteers
- 47 people
- Sponsor
- Krystal Biotech, Inc.
Cystic Fibrosis
A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis
The Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator…
- Trial name
- NCT05095246
- Testing
- KB407 (Nebulization)
- Where
- Australia
- Sponsor
- Krystal Biotech, Inc.
Autosomal Recessive Ichthyosis
Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)
KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI).
- Trial name
- NCT05735158
- Testing
- KB105
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
- Conditions
- Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
- Trial name
- GEM-3 (NCT04491604)
- Testing
- Topical Beremagene Geperpavec
- Where
- 3 sites in United States
- Volunteers
- 31 people
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa
A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients
This study was conducted to assess the safety and efficacy of topical Beremagene Geperpavec (KB103, HSV1-COL7) on DEB patients.
- Trial name
- GEM-1 (NCT03536143)
- Testing
- Topical beremagene geperpavec
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with Dystrophic Epidermolysis Bullosa (DEB) for inclusion into the Krystal Biotech Phase III protocol of B-VEC…
- Trial name
- NCT04214002
- Where
- United States
- Sponsor
- Krystal Biotech, Inc.
TGM-1 Related Autosomal Recessive Congenital Ichthyosis
Topical KB105 Gene Therapy for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)
This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically…
- Trial name
- NCT04047732
- Testing
- KB105
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
Long-Term Follow-up Protocol
The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc.
- Conditions
- Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
- Trial name
- NCT04917887
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Krystal Biotech, Inc.