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DNK333

Phase 2

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

DNK333 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2006

DNK333 target and mechanism

Molecular targetTACR1
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment395

FDA Designations

No designations recorded

DNK333 clinical trials

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
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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
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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
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Competitive Landscape -Irritable Bowel Syndrome 15 trials

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Frequently asked questions about DNK333

What is DNK333?

DNK333 is an investigational small molecule developed by Novartis AG for gastrointestinal and dermatologic conditions. It has been studied in Phase 2 clinical trials for irritable bowel syndrome, diarrhea-predominant irritable bowel syndrome (IBS-D), and pruritus in patients with atopic dermatitis. It is not approved and remains in clinical development.

What is DNK333 used for in IBS-D?

DNK333 was studied as a treatment for diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women. Phase 2 trials evaluated its efficacy, safety, and tolerability in this population. The trials have been completed, and the drug is not approved for IBS-D or any other indication.

What does DNK333 target?

DNK333 targets TACR1, also known as the neurokinin 1 (NK1) receptor. It acts as a TACR1 antagonist, meaning it blocks the activity of this receptor. TACR1 antagonism is the mechanism explored in its clinical development for IBS-D and pruritus in atopic dermatitis.

Who makes DNK333?

DNK333 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 clinical trials evaluating DNK333 in irritable bowel syndrome and pruritus in atopic dermatitis.

What phase is DNK333 in?

DNK333 is in Phase 2. All of its clinical trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is DNK333 in?

DNK333 has been evaluated in three completed Phase 2 trials: NCT01033097 in atopic dermatitis pruritus, NCT00699166 in IBS-D, and NCT00394173 in IBS-D. All were randomized, double-blind, and placebo-controlled, enrolling adults aged 18 and older.