A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp (AK004)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03285490|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: KX2-391 Ointment 1% Drug: Placebo||Phase 3|
This study will be a double-blinded, multicenter, activity, and safety study of KX2-391 Ointment administered topically to the face or scalp of subjects with actinic keratosis.
The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible subjects will receive X consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations will be performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will test KX2-391 Ointment 1% against a placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All Central Vendors and the sponsor will be masked. The sponsor will unblind at the end of Day 57.|
|Official Title:||A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 29, 2019|
Experimental: KX2-391 Ointment 1%
KX2-391 Ointment will be applied once daily for X consecutive days on the face or scalp
Drug: KX2-391 Ointment 1%
The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical AK on the face or scalp.
Placebo Comparator: Placebo
The Vehicle Ointment will be applied once daily for X consecutive days on the face or scalp
Vehicle Ointment wil be used in subjects with Clinically typical AK on the face or scalp.
- Complete response rate [ Time Frame: 57 Days ]Efficacy will be evaluated by the proportion of subjects achieving complete clearance of all AK in the selected area in the study drug group versus the placebo group.
- Local Skin Reactions [ Time Frame: 15 Months ]To evaluate the safety of KX2-391 Ointment 1% by the proportion of local skin reactions
- Adverse Events [ Time Frame: 15 Months ]To evaluate the safety of KX2-391 Ointment 1% by the proportion of adverse events
- Abnormal Laboratory Assessments [ Time Frame: 15 Months ]To evaluate the safety of KX2-391 Ointment 1% by the proportion of abnormal laboratory assessments
- Partial Response [ Time Frame: 57 Days ]Partial response is defined as ≥75% clearance of AK lesions in the selected treatment area, comparing the study drug group versus the placebo group
- Reduction of AK lesions [ Time Frame: 57 Days ]The proportion of AK lesions which reduce in the selected area.
- Complete response rate [ Time Frame: 12 months ]Efficacy will be evaluated by the proportion of subjects achieving complete clearance of all AK in the selected area in the study drug group versus the placebo group in recurrence follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285490
Show 30 Study Locations
|Study Chair:||Jane Fang, MD||Athenex, Inc.|