Recent Updates
Recently added Catalysts

DNK333

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Mar 21, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

DNK333 · 3 trials · 3 indications

Phase 2 3
NCT01033097Safety and Efficacy of DNK333 in Atopic Dermatitis PatientsPruritus in Patients With Atopic Dermatitis
COMPLETED80 Analytics
NCT00394173Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)Irritable Bowel Syndrome With Diarrhea (IBS-D)
COMPLETED180 Analytics
NCT00699166Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)Irritable Bowel Syndrome
COMPLETED135 Analytics
PHASE2COMPLETED
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
Pruritus in Patients With Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Irritable Bowel Syndrome With Diarrhea (IBS-D)Unlock trial analytics
PHASE2COMPLETED
Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
2 weeks
Satisfactory relief of IBS-related abdominal pain/discomfort
4 weeks
Satisfactory relief of overall IBS-D symptoms
4 weeks
Change from baseline in average stool form score at 2 weeks
2 weeks

Secondary Endpoints

Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)
2 weeks
Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)
2 weeks
Safety and tolerability of DNK333 in atopic dermatitis patients
2 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DNK333 5 mgEXPERIMENTAL -
Placebo to DNK333 5mgPLACEBO_COMPARATOR -
DNK333 25 mgEXPERIMENTAL -
Placebo to DNK333 25 mgPLACEBO_COMPARATOR -
DNK333 100 mgEXPERIMENTAL -
Placebo to DNK333 100 mgPLACEBO_COMPARATOR -
Betamethasone 4 mgACTIVE_COMPARATOR -
DNK333 1 mgEXPERIMENTAL -
placebo 1mgPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DNK333 5 mgDRUG5 mg oral
Placebo to 5 mgDRUG5 mg placebo oral
DNK333 25 mgDRUG25 mg oral
Placebo to 25 mgDRUG25 mg placebo oral
DNK333 100 mgDRUG100 mg oral
Placebo to 100 mgDRUG100 mg placebo oral
Betamethasone 4 mgDRUG4 mg oral
DNK333 1mgDRUG1 mg oral
Placebo to 1mgDRUG1 mg placebo oral
DNK333DRUGDNK333 25mg b.i.d. given orally for 4 weeks
PlaceboDRUGMatching placebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria: * Requirement of systemic therapy * Itch VAS score higher than 50 mm * EASI score higher than 8 Exclusion Criteria: * Women of child-bearing potential who are not ...

Countries:GermanyUnited StatesCanada
Unlock Eligibility Criteria

Frequently asked questions about DNK333

What is DNK333 used for?

DNK333 is an investigational small molecule being studied for irritable bowel syndrome with diarrhea (IBS-D), irritable bowel syndrome, and pruritus in patients with atopic dermatitis. It is being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development.

Who makes DNK333?

DNK333 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for gastrointestinal and dermatological indications.

What phase is DNK333 in?

DNK333 is in Phase 2 clinical development. It has completed three Phase 2 trials, including studies in women with diarrhea-predominant irritable bowel syndrome and in patients with atopic dermatitis-related pruritus. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is DNK333 in?

DNK333 has completed three Phase 2 clinical trials: NCT00394173 and NCT00699166 in women with diarrhea-predominant irritable bowel syndrome, and NCT01033097 in patients with pruritus associated with atopic dermatitis. These trials were conducted in the United States, Canada, and Germany.

Is DNK333 the same as any other drug?

DNK333 is the primary name for this investigational compound. No alternative names have been reported in the clinical trial data. The drug is being studied under this identifier across all its Phase 2 trials for irritable bowel syndrome and atopic dermatitis-related pruritus.