Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) (NCT NCT03421197)

Last Updated: 2022-04-01

Results Overview

The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

426 participants

Primary outcome timeframe

End of Week 24

Results posted on

2022-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	PPC-06 400 mg QD Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Overall Study STARTED	105	107	107	107
Overall Study COMPLETED	67	68	56	62
Overall Study NOT COMPLETED	38	39	51	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PPC-06 400 mg QD n=105 Participants Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID n=107 Participants Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID n=107 Participants Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID n=107 Participants White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets	Total n=426 Participants Total of all reporting groups
Age, Continuous	48.0 years STANDARD_DEVIATION 13.18 • n=5 Participants	51.0 years STANDARD_DEVIATION 12.29 • n=7 Participants	50.2 years STANDARD_DEVIATION 13.74 • n=5 Participants	49.3 years STANDARD_DEVIATION 12.59 • n=4 Participants	49.6 years STANDARD_DEVIATION 12.96 • n=21 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	43 Participants n=7 Participants	43 Participants n=5 Participants	43 Participants n=4 Participants	169 Participants n=21 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	64 Participants n=7 Participants	64 Participants n=5 Participants	64 Participants n=4 Participants	257 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	96 Participants n=7 Participants	92 Participants n=5 Participants	97 Participants n=4 Participants	382 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United States	105 participants n=5 Participants	107 participants n=7 Participants	107 participants n=5 Participants	107 participants n=4 Participants	426 participants n=21 Participants
Psoriasis Area and Severity Index (PASI)	18.41 units on a scale STANDARD_DEVIATION 6.377 • n=5 Participants	18.56 units on a scale STANDARD_DEVIATION 8.004 • n=7 Participants	18.00 units on a scale STANDARD_DEVIATION 6.680 • n=5 Participants	17.26 units on a scale STANDARD_DEVIATION 6.169 • n=4 Participants	18.05 units on a scale STANDARD_DEVIATION 6.842 • n=21 Participants

PRIMARY outcome

Timeframe: End of Week 24

Population: Full Analysis Set (FAS) Population which included all randomized subjects who received at least one dose of IP and had at least one post-dose efficacy assessment.

Outcome measures

Outcome measures
Measure	PPC-06 400 mg QD n=101 Participants Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID n=102 Participants Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID n=101 Participants Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID n=102 Participants White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24	39.7 percentage of total participants	47.2 percentage of total participants	44.3 percentage of total participants	20.0 percentage of total participants

PRIMARY outcome

Timeframe: End of Week 24

Population: Full Analysis Set (FAS) Population included all randomized subjects who received at least one dose of IP and had at least one post-dose efficacy assessment.

The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1) Score Grade Definition 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.

Outcome measures

Outcome measures
Measure	PPC-06 400 mg QD n=101 Participants Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID n=102 Participants Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID n=101 Participants Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID n=102 Participants White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1	35.7 percentage of total participants	41.4 percentage of total participants	44.4 percentage of total participants	22.0 percentage of total participants

Adverse Events

PPC-06 400 mg QD

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

PPC-06 400 mg BID

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

PPC-06 600 mg BID

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Placebo BID

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PPC-06 400 mg QD n=105 participants at risk Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID n=107 participants at risk Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID n=106 participants at risk Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID n=107 participants at risk White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Respiratory, thoracic and mediastinal disorders Dyspnoea/Shortness of Breath	0.95% 1/105 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Gastrointestinal disorders Diverticulitis	0.95% 1/105 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Infections and infestations Diverticulitis	0.95% 1/105 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Immune system disorders Hypersensitivity	0.00% 0/105 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/105 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/105 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Nervous system disorders Cervical cord compression	0.00% 0/105 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Infections and infestations Staphylococcal skin infection	0.00% 0/105 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/106 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.

Other adverse events

Other adverse events
Measure	PPC-06 400 mg QD n=105 participants at risk Tepilamide Fumarate 400 mg once per day PPC-06 400 mg QD: Tepilamide Fumarate 400 mg tablet once per day	PPC-06 400 mg BID n=107 participants at risk Tepilamide Fumarate 400 mg twice per day PPC-06 400 mg BID: Tepilamide Fumarate tablets 400 mg twice per day	PPC-06 600 mg BID n=106 participants at risk Tepilamide Fumarate 600 mg twice per day PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day	Placebo BID n=107 participants at risk White placebo tablet to mimic Tepilamide Fumarate Placebo: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Blood and lymphatic system disorders Lymphopenia	3.8% 4/105 • Number of events 4 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	3.7% 4/107 • Number of events 5 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	9.4% 10/106 • Number of events 10 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Blood and lymphatic system disorders Eosinophilia	4.8% 5/105 • Number of events 5 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	5.6% 6/107 • Number of events 7 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	4.7% 5/106 • Number of events 5 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Gastrointestinal disorders Diarrhea	6.7% 7/105 • Number of events 12 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	17.8% 19/107 • Number of events 20 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	22.6% 24/106 • Number of events 32 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	4.7% 5/107 • Number of events 5 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Gastrointestinal disorders Nausea	6.7% 7/105 • Number of events 8 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	6.5% 7/107 • Number of events 7 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	10.4% 11/106 • Number of events 11 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	1.9% 2/107 • Number of events 2 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Gastrointestinal disorders Abdominal Pain	3.8% 4/105 • Number of events 4 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	4.7% 5/107 • Number of events 6 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	11.3% 12/106 • Number of events 13 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.00% 0/107 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.
Infections and infestations Urinary Tract Infection	2.9% 3/105 • Number of events 3 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	0.93% 1/107 • Number of events 1 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	5.7% 6/106 • Number of events 7 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.	1.9% 2/107 • Number of events 3 • Adverse events were collected from the time of signing the informed consent, up to 30 days after the last dose. Adverse events were assessed at all study visits. Adverse events were monitored by the investigator from the time of signing informed consent, up to 30 days after the subject has stopped study treatment or until the AE had resolved or stabilized. Adverse events were evaluated in the Safety Population.

Additional Information

Srinivas Sidgiddi, Sr Director, Clinical Development

Dr Reddy's Laboratories

Phone: 609-375-9910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place